Computer-Based Weight Maintenance in Primary Care (MAINTAIN-PC)
|ClinicalTrials.gov Identifier: NCT01946191|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : October 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|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|
|Actual Study Start Date :||October 1, 2013|
|Actual Primary Completion Date :||September 5, 2017|
|Estimated Study Completion Date :||August 1, 2018|
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 adviceBehavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health recordBehavioral: 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)
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record
- Body weight [ Time Frame: Day 1 vs. 30 Months ]Change in body weight from baseline (day 1) until the end of study (30 months).
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946191
|United States, Pennsylvania|
|Center for Research on Health Care|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Kathleen M McTigue, MD, MPH, MS||University of Pittsburgh|