Pilot Tests to Optimize the Delivery of Energy Balance Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02194387
First received: July 16, 2014
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

High Risk Families:

The goal of this research study is to learn more about an exercise and weight management program for high-risk women in families affected by TNBC or HGSOC. Different kinds of interventions will be used and compared to learn which are more helpful.

MD Anderson Employees:

The goal of this research study is to learn more about an exercise and weight management program for MD Anderson employees. Different kinds of interventions will be used and compared to learn which are more helpful.


Condition Intervention
Breast Cancer
Ovarian Cancer
Behavioral: Telephone Coaching
Behavioral: Text Messaging
Behavioral: Social Networking
Behavioral: Daily Self-Monitoring
Behavioral: Weekly Self-Monitoring
Behavioral: Questionnaires
Behavioral: Email Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Tests to Optimize the Delivery of Energy Balance Interventions

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Waist Circumference Change [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The primary endpoint is waist circumference change (4 month post-intervention minus the baseline). Power calculation based on the methodology proposed by Dziak et al.


Estimated Enrollment: 80
Study Start Date: September 2014
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone Coach + Texts + Social Network + Daily Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Texts + Social Network + Weekly Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Texts + Daily Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Texts + Weekly Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Social Network + Daily Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Social Network + Weekly Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Daily Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Weekly Self-Monitor

Telephone Coaching: Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 15-30 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Email Coach + Texts + Social Network + Daily Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Texts + Social Network + Weekly Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Texts + Daily Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Texts + Weekly Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Text Messaging: Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant called during the first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 where coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach asks.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Social Network + Daily Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Social Network + Weekly Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Social Networking: Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Social Networking
Participant invited to use an online forum to discuss their fitness goals with other participants in study who are receiving social networking.
Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Daily Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Daily Self-Monitoring: Participant enters additional information about their diet and activity every day through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Daily Self-Monitoring
Participant enters additional information about their diet and activity every day through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.
Experimental: Email Coach + Weekly Self-Monitor

Email Coaching: Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Weekly Self-Monitoring: Participant enters additional information about their diet and activity once a week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Weekly Self-Monitoring
Participant enters additional information about their diet and activity once a week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Behavioral: Email Coaching
Participant called during first week to discuss the interventions. This call will last about 10-15 minutes. Participant then receives 1 email each week in Weeks 2-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pilot 1 and 2: BMI of 25 or higher OR < 150 minutes of moderate to vigorous exercise per week OR <5 servings of fruit and vegetables per day
  2. Pilot 1 and Pilot 2: Capable of participating in moderate-vigorous unsupervised exercise
  3. Pilot 1 and Pilot 2: Have a cellular telephone and are able and willing to send and receive text messages
  4. Pilot 1 and Pilot 2: 18 years old or older
  5. Pilot 1 and Pilot 2: Able to read and write English
  6. Pilot 2 (patient): BRCA (BReast CAncer) positive breast and/or ovarian cancer survivors of stage I through III, at least 3 months post-surgery and not currently receiving radiation therapy or cytotoxic chemotherapy
  7. Pilot 2 (family member): Female biological relatives of BRCA-positive survivors who are cancer-unaffected, BRCA-positive, and who have not undergone risk-reducing mastectomy
  8. Pilot 2 (family member): Female biological relatives of BRCA-positive survivors who are cancer unaffected, BRCA-negative

Exclusion Criteria:

  1. Pilot 1 and Pilot 2: Unable to walk without crutches, walker, cane, or other assistive device
  2. Women who are pregnant (by self-report)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194387

Contacts
Contact: Karen Basen-Engquist, PHD, BA, MPH 713-745-3123

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PHD, BA, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02194387     History of Changes
Other Study ID Numbers: 2014-0230
Study First Received: July 16, 2014
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Ovarian Cancer
Triple negative breast cancer
High-grade serous ovarian cancer
Cancer survivors
TNBC
BRCA-positive survivor
HGSOC
Female biological relative of a BRCA positive TNBC or HGSOC survivor
Employees at MD Anderson
Multi-phase Optimization Strategy
MOST
Energy balance interventions
EB
Telephone Coaching
Text Messaging
Social Networking
Daily Self-Monitoring
Weekly Self-Monitoring
Email Coaching
Questionnaires
Surveys

Additional relevant MeSH terms:
Ovarian Neoplasms
Breast Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Breast Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014