Overview

This trial is active, not recruiting.

Conditions body weight, weight loss, motor activity
Treatments health coach electronic communication and support, online self-monitoring, real-time updates to primary care physicians
Sponsor University of Pittsburgh
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date October 2013
End date September 2017
Trial size 194 participants
Trial identifier NCT01946191, 1R18HS021162

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians
health coach electronic communication and support
Health coach reviews responses to weight-related surveys and provides feedback and advice
online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record
real-time updates to primary care physicians
Primary care physicians will receive updates through electronic health record system before each scheduled appointment
(Active Comparator)
Online self-monitoring
online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record

Primary Outcomes

Measure
Body weight
time frame: Day 1 vs. 30 Months

Secondary Outcomes

Measure
Maintenance of 5% weight loss
time frame: Day 1 vs. 30 Months
BMI
time frame: Day 1 vs. 30 Months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
Principal investigator Margaret B Conroy, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.