Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pilot Tests to Optimize the Delivery of Energy Balance Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 16, 2016
Last verified: August 2016
  Purpose

Objectives:

Pilot 1 Primary aim: To explore the feasibility of using the Multi-phase Optimization Strategy (MOST) approach to optimize energy balance (EB) interventions in a sample of MD Anderson employees.

Pilot 2 Primary aim: To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of BRCA (BReast CAncer) positive and Lynch Syndrome positive individuals and their family members.

Pilot 3 Primary aim: To explore the feasibility of using the MOST approach to optimize energy balance interventions in a sample of CLL (Chronic Lymphocytic Leukemia) patients.


Condition Intervention
Breast Cancer
Ovarian Cancer
Behavioral: Telephone Coaching
Behavioral: Text Messaging
Behavioral: Resistance Training
Behavioral: Daily Self-Monitoring
Behavioral: 4 - 7 Days a Week 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: 272
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 + Resistance Training + Daily Self-Monitor

Telephone Coaching: Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
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 + Resistance Train + Weekly Self-Monitor

Telephone Coaching: Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per 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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.

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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Text Messaging: Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Resistance Training + Daily Self-Monitor

Telephone Coaching: Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
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 + Resistance Training + Weekly Self-Monitor

Telephone Coaching: Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Behavioral: Telephone Coaching
Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Phone Coach + Daily Self-Monitor

Telephone Coaching: Participant has 30-45 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 30-45 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 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Telephone Coaching
Participant has 30-45 minute telephone calls 1 time each week with a telephone coach trained in motivational interviewing.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.
Behavioral: Questionnaires
Questionnaire completion at baseline, 8 weeks and 16 weeks.
Other Name: Surveys
Experimental: Email Coach + Texts + Resistance Training + 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 receives 8-12 messages/week, 1-3 messages/day during the 16 week intervention period.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

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 receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
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 1-16 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 1-16 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 receives 8-12 messages/week, 1-3 messages/day during the 16 week intervention period.

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

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per 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 1-16 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 1-16 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 receives 8-12 messages/week, 1-3 messages/day during the 16 week intervention period.

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 receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
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 1-16 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 receives 8-12 messages/week, 1-3 messages/day during the 16 week intervention period.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Text Messaging
Participant receives 7-12 messages/week, 1-3 messages/day during the 16 week intervention period.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per 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 1-16 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 + Resistance Training + 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 1-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

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: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
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 1-16 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 + Resistance Training + 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 1-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

Resistance Training: Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: Resistance Training
Participant given set of resistance exercise bands, a list of exercises and instructional videos on how to do each exercise. Participant logs resistance exercises on a weekly activity log.
Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per 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 1-16 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 1-16 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 1-16 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 1-16 in which the coach provides feedback about participant's goals and asks 1-2 questions similar to what telephone coach would ask.

4 - 7 Days a Week Self-Monitoring: Participant enters additional information about their diet and activity 4-7 days per week through the FitBit website.

Questionnaire completion at baseline, 8 weeks and 16 weeks.

Behavioral: 4 - 7 Days a Week Self-Monitoring
Participant enters additional information about their diet and activity 4-7 days per 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 1-16 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   (Adult, Senior)
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 1 and 2: Have access to internet
  7. Pilot 2: BRCA positive OR Lynch Syndrome positive individuals
  8. Pilot 2 (family member): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch Syndrome positive individuals

Exclusion Criteria:

  1. Pilot 1 and Pilot 2: Unable to walk without crutches, walker, cane, or other assistive device
  2. Pilot 1 and Pilot 2: Women who are pregnant (by self-report)
  3. Pilot 1 and Pilot 2: Less than 3 months post-surgery
  4. Pilot 2: Currently received radiation therapy or cytoxic chemotherapy
  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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02194387     History of Changes
Other Study ID Numbers: 2014-0230  NCI-2015-00095 
Study First Received: July 16, 2014
Last Updated: August 16, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 23, 2016