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Computer-Based Weight Maintenance in Primary Care (MAINTAIN-PC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01946191
First Posted: September 19, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kathleen McTigue, University of Pittsburgh
  Purpose
The purpose of this study is to test whether online tracking tools and weight maintenance coaching visits for patients and real-time electronic progress reports for primary care providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients who have lost ≥ 5% of their body weight.

Condition Intervention
Body Weight Weight Loss Motor Activity Behavioral: Health coach electronic communication and support Behavioral: Online self-monitoring Behavioral: Real-time updates to Primary Care physicians

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care

Resource links provided by NLM:


Further study details as provided by Kathleen McTigue, University of Pittsburgh:

Primary Outcome Measures:
  • Body weight [ Time Frame: Day 1 vs. 30 Months ]
    Change in body weight from baseline (day 1) until the end of study (30 months).


Secondary Outcome Measures:
  • Maintenance of 5% weight loss [ Time Frame: Day 1 vs. 30 Months ]
    Secondarily, the maintenance of a 5% weight loss from baseline (day 1) to end of study (30 months).

  • BMI [ Time Frame: Day 1 vs. 30 Months ]
    Change in body mass index from baseline (day 1) to the end of the study (30 months).


Other Outcome Measures:
  • Patient Satisfaction [ Time Frame: 12 Months and 30 Months ]
    Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (30 months).

  • PCP Satisfaction [ Time Frame: 12 Months and 30 Months ]
    PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (30 months).


Enrollment: 194
Actual Study Start Date: October 1, 2013
Estimated Study Completion Date: August 1, 2018
Primary Completion Date: September 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continued Coaching (CC)
Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians
Behavioral: Health coach electronic communication and support
Health coach reviews responses to weight-related surveys and provides feedback and advice
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Behavioral: Real-time updates to Primary Care physicians
Primary care physicians will receive updates through electronic health record system before each scheduled appointment
Active Comparator: Tracking Only (TO)
Online self-monitoring
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record

Detailed Description:

The investigators aim to address the key problem of how to implement U.S.Preventive Services Task Force obesity treatment recommendations in a cost-effective manner. The investigators propose a Randomized Clinical Trial - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-PC) - to test whether a group of primary care patients who have lost at least 5% of their body weight in the past year will be more likely to maintain their weight loss with a multifaceted intervention that includes online tracking tools, web-based "coaching" visits, and PCP engagement through real time electronic progress reports with counseling tips than when using online tracking tools alone. By integrating this intervention within an existing electronic health record and clinical flow, the investigators maximize potential for future dissemination.

The MAINTAIN-PC study draws upon recommendations for the design of practical clinical and behavioral trials. The investigators will assess multiple relevant outcomes across clinically meaningful treatment strategies. The investigators will recruit a sample that is diverse in terms of gender, BMI and co-morbidity status, with a racial/ethnic mix reflective of the region, and that includes Agency for Healthcare Research Quality priority populations. The investigators will include clinical practices with diverse characteristics, and have selected interventionists who reflect the level of training typically seen among primary care clinic staff. The investigators will recruit 30-40 participants a month, with recruitment lasting 5-6 months, and each participant in both CC and TO arms receiving a 30 month intervention. The last year of the study will focus on analyses, including cost-effectiveness analyses.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • Intentional & verified weight loss of greater than or equal to 5% of body weight in past two years with previous BMI greater than or equal to 25.
  • Patient of participating PCP
  • Has/willing to get electronic personal health record account

Exclusion Criteria:

  • Unable to perform moderate exercises according to PCP
  • Current or planned pregnancy
  • Currently breastfeeding
  • Recent or planned bariatric surgery
  • Edema due to medical condition
  • No access to computer
  • Treated for cancer or thyroid disease in past year
  • Unable to attend group session or comply with requirements
  • Any other reason as determined by the Principal Investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946191


Locations
United States, Pennsylvania
Center for Research on Health Care
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Kathleen M McTigue, MD, MPH, MS University of Pittsburgh
  More Information

Publications:
Responsible Party: Kathleen McTigue, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01946191     History of Changes
Other Study ID Numbers: 1R18HS021162 ( U.S. AHRQ Grant/Contract )
First Submitted: September 16, 2013
First Posted: September 19, 2013
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kathleen McTigue, University of Pittsburgh:
Weight maintenance
Electronic health record
Primary care

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes