Integrating Online Weight Management With Primary Care Support
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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. 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.

           b. To compare the effectiveness of the combined intervention (online weight management
           program plus population management support) with the stand-alone online program and with
           usual care.

           Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months
           compared with the stand-alone online program and with usual care.

        2. To identify mediators of the combined intervention and the stand-alone online program.

           Hypothesis 2: The effects of the combined intervention and the stand-alone online
           program on weight loss will be mediated by patients' level of engagement, changes in
           self-efficacy, and changes in diet and physical activity.

        3. To explore whether the effectiveness of the combined intervention and the stand-alone
           weight management program varies by patient characteristics.

      Hypothesis 3: The interventions will be more effective among patients who are younger, white,
      and higher socioeconomic status, although the population management strategy may help to
      reduce these differences.
    

Detailed description: 
      Focus Groups and Key Informant Interviews:

      Focus groups will be conducted with 5 to 7 patients at the beginning of the study to obtain
      their feedback about an online program and the population health management support strategy.
      To be eligible for the focus groups, patients must have a Brigham and Women's Hospital (BWH)
      primary care clinician, be between ages 20-70 years old, and have a recent BMI (in the past
      year) between approximately 27 and 40 kg/m2. They should also be interested in weight
      management and/or motivated to lose weight.

      Phone interviews will be conducted at the end of the study to solicit feedback on the BMIQ
      program and the population health management intervention. Patients in the PROPS Study who
      are assigned to the online program or combined intervention arm, reach the 18-month
      timepoint, and complete the final study survey are eligible and will be invited to
      participate.

      Key Informant Interviews will be conducted at the beginning and the end of the study. To be
      eligible, the key informants must be clinicians or other staff who provide services to
      patients at one of the participating BWH primary care practices. There are a total of 165
      clinicians in these practices, including staff physicians, residents or fellows, and nurse
      practitioners or physician assistants. Approximately 7 clinicians at each timepoint will be
      recruited as key informants and will also be asked to complete electronic surveys during the
      trial.

      After adapting the online weight management program and integrating it with the population
      management support strategy based on our focus groups and key informant interviews,
      investigators will conduct a three-arm cluster-randomized trial to compare the effectiveness
      of the combined intervention (online weight management program plus population management
      support) with the stand-alone online weight management program and with usual care. This will
      be a pragmatic clinical trial conducted in approximately 14 BWH primary care practices. To be
      eligible for the trial, patients must have an upcoming scheduled visit at a BWH primary care
      practice, BMI between 27 and 39.9 kg/m2 at enrollment, and a diagnosis of type 2 diabetes or
      hypertension. They also must be between ages 20 and 70 (inclusive) at enrollment, speak
      English or Spanish, and have access the Internet using a computer, tablet, or smart phone.
      Finally, patients must be motivated to lose weight. Investigators plan to recruit a total of
      840 patients for the study (280 per arm). Patients who enroll in the trial will attend
      regular primary care visits at their practices and also will complete surveys by e-mail,
      regular mail, or phone.
    

Intervention name(s): Online weight management program; Population health management support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Weight Reduction Programs; Weight Loss Programs; Obesity