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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Margaret (Molly) Conroy, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01946191
First received: September 16, 2013
Last updated: December 1, 2016
Last verified: December 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Pittsburgh:

Primary Outcome Measures:
  • Body weight [ Time Frame: Day 1 vs. 30 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Study Start Date: October 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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: Margaret B Conroy, MD, MPH University of Pittsburgh
  More Information

Responsible Party: Margaret (Molly) Conroy, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01946191     History of Changes
Other Study ID Numbers: 1R18HS021162 
Study First Received: September 16, 2013
Last Updated: December 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 09, 2016