Integrating Online Weight Management With Primary Care Support

NCT02656693 | Completed Results

• 1 other identifier: 2015P002372
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are:

1. 1.a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention.
2. 2.To identify mediators of the combined intervention and the stand-alone online program.
3. 3.To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics.

Conditions

Obesity

Keywords

Weight Reduction Programs; Weight Loss Programs; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight at 12 Months

  change in body weight from enrollment to 12 months

  12 months after the initial primary care visit

Secondary Outcomes (25)

• Change in Body Weight at 6 Months

  6 months after the initial primary care visit

• Change in Body Weight at 18 Months

  18 months after the initial primary care visit

• Percent Weight Change at 6 Months

  6 months after the initial primary care visit

• Percent Weight Change at 12-Months

  12 months after the initial primary care visit

• Percent Weight Change at 18-Months

  18 months after the initial primary care visit

Study Arms (3)

Online Program Only

EXPERIMENTAL

Patients will use an online weight management program called BMIQ, with minimal additional support.

Behavioral: Online weight management program

Combined Intervention

EXPERIMENTAL

Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.

Behavioral: Online weight management program; Behavioral: Population health management support

Usual Care

NO INTERVENTION

Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)

Interventions

Online weight management program BEHAVIORAL

Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.

Combined Intervention; Online Program Only

Population health management support BEHAVIORAL

Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.

Combined Intervention

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• upcoming or recent visit at primary care practice affiliated with Brigham and Women's Hospital
• age 20-70
• diagnosis of type 2 diabetes and/or hypertension
• BMI \>= 27 and \< 40 kg/m2
• motivated to lose weight
• valid email address and access the Internet using a computer, tablet, or smartphone
• English or Spanish-speaking

You may not qualify if:

• \. on insulin for treatment of their diabetes 2. MI, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in last 6 months 3. Unstable angina 4. Currently pregnant or planning to become pregnant during the study period 5. Currently lactating 5. Has had bariatric surgery or planning to have bariatric surgery 6. \>5% weight loss in the last 6 months 7. Severe psychiatric illness or impaired mental status 8. Active or diagnosed history of and/or self-reported history of eating disorders 9. Self-reported average consumption of \> 14 alcoholic drinks/week 10. Any serious medical condition that would affect weight loss or for which weight loss is contraindicated, including active cancer (excluding non-melanoma skin cancer) or currently being treated for cancer, end stage renal disease (ESRD) on dialysis, etc.
• \. On comfort care measures, hospice, or in nursing home 12. Participating in a contra-indicative research study 13. Use of prescription or over-the-counter weight loss medications or an all-liquid diet program in the last 6 months or currently 14. Any other medical contraindication for weight loss or physical activity, or any other reason that the PCP or their delegate (e.g., LPN or RN) did not deem the patient appropriate for the study

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Baer HJ, Rozenblum R, De La Cruz BA, Orav EJ, Wien M, Nolido NV, Metzler K, McManus KD, Halperin F, Aronne LJ, Minero G, Block JP, Bates DW. Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial. JAMA. 2020 Nov 3;324(17):1737-1746. doi: 10.1001/jama.2020.18977.

  PMID: 33141209 DERIVED

• Baer HJ, De La Cruz BA, Rozenblum R, Nolido NV, Orav EJ, Metzler K, Block JP, Halperin F, McManus KD, Aronne LJ, Minero G, Bates DW. Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies). Contemp Clin Trials. 2020 Aug;95:106026. doi: 10.1016/j.cct.2020.106026. Epub 2020 May 16.

  PMID: 32428586 DERIVED

• Rozenblum R, De La Cruz BA, Nolido NV, Adighibe I, Secinaro K, McManus KD, Halperin F, Block JP, Bates DW, Baer HJ. Primary Care Patients' and Providers' Perspectives about an Online Weight Management Program: a Qualitative Study. J Gen Intern Med. 2019 Aug;34(8):1503-1521. doi: 10.1007/s11606-019-05022-6. Epub 2019 May 31.

  PMID: 31152361 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heather J. Baer, ScD
• Organization: Brigham and Women's Hospital

hbaer@bwh.harvard.edu

617-525-7503

Study Officials

• Heather Baer, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 15, 2016
• Study Start: July 19, 2016
• Primary Completion: November 8, 2018
• Study Completion: May 8, 2019
• Last Updated: November 5, 2020
• Results First Posted: August 9, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)