HealthyMe Online Weight Management Education/HealthyMe at Home
Condition: Diabetes
Study type: Interventional

Summary: 
      The main objective for this project is to identify effective methods of treating obesity in
      at-risk populations. The investigators will be comparing weight loss from usual care, in
      person, and video conference weight loss programs. The investigators will follow 210
      participants for 12 months to see if they lose and maintain 2kg of weight. The investigators
      will also compare the costs of video conference versus in person administered programs.

      Potentially eligible participants will be identified based on data in the Regenstrief Medical
      Records System or by referral from the Wishard HealthyMe weight loss program staff or a
      Wishard Community Health Center (CHC) primary care provider. The PBRN staff will carry-out
      initial recruitment. Following consent, a baseline assessment will be performed and each
      participant will be randomized into one of three groups: usual care control, in person weight
      loss or online video conference weight loss. At 6 and 12 months a follow up assessment will
      be performed and compared to measures from the investigators baseline assessment. Total costs
      for each program will be compared as well.

      The weight loss interventions involve group meetings two times per week where education,
      exercise, and social support are provided. Participants will also receive a detailed
      education booklet. Those randomized to the in-person group will meet in the CHC and those in
      the video-conference group will meet online in a multi-party video-conference. All
      participants will receive usual CHC care.
    

Detailed description: 
      Recruitment will occur in person or by phone by the Practice Based Research Network (PBRN).
      Prior to recruitment, patients will have been identified as potentially eligible by having a
      BMI of ≥30<50, age 40-64 years, Community Health Center visit within 12 months and no type 2
      diabetes, psychosis or bipolar disorder, current cancer treatment or medication prescriptions
      for drugs that may unduly influence weight. All of this would be determined from the
      Regenstrief Medical Records System, by referral from HealthyMe staff, or a CHC primary care
      provider. Potentially eligible persons must then be approved for the study and
      moderate-intensity exercise by their primary care provider before the recruitment call and
      screener from the PBRN. The screener assesses other eligibility criteria such as recent
      weight loss program enrollment, current physical activity level, residence plans, phone
      availability, etc. Those who are eligible and initially interested will be referred to the
      study staff.

      Staff will call, describe the study and arrange for an in-home appointment with the potential
      participant. At the participant's home, the staff will again describe the study and consent
      the participant. The first assessment will take place at this time. The baseline assessment
      pertains of demographic questions, living situation questions, smoking status, weight
      history, Patient Health Questionnaire (PHQ), New Vital Sign (NVS) Nutrition Literacy and
      Numeracy Survey, the Subjective Numeracy Scale, Short Form 36, Social Support and Exercise,
      Social Support and Eating Habits, Exercise enjoyment scales, Wellness Evaluation of Lifestyle
      (WEL), low fat diet efficacy scale, exercise self efficacy scale, and an online dietary
      recall (ASA 24) provided by the National Cancer Institute as well as blood pressure, weight,
      height and waist circumference. They will also be asked to wear an armband accelerometer for
      two weeks to let the staff know how much energy they are expending.

      The participants will be randomized to three different arms: usual care, in center education
      and exercise, or education and exercise via video conference. The attached handouts,
      placemats, as well as portion control dinnerware will be given to the active arms of the
      study. The sessions for both groups will occur twice a week for approximately 75 minutes.
      Those randomized to the video conference arm will have a computer with Internet access
      installed in their home. All Internet related expenses will be covered by the study during
      the duration of the classes and the computer will be removed at the end of the study.

      Sessions for the two active arms will occur twice per month in months 6-9 and once a month
      for months 10-12. They will include an exercise and educational portion to last about 75
      minutes.

      We will be measuring change in weight, body measurements and improvements in the NVS at six
      months and have a final assessment at 12 months. They will again be asked to wear the
      accelerometer for two weeks and to answer the questions in the attached survey. Their weight
      and blood pressure will again be recorded.

      During the course of the study, participants may need to be called to set up appointments,
      remind them of sessions or assist them with their equipment.
    

Intervention name(s): Education and exercise
Intervention type(s): Behavioral
Intervention description(s): The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Management; Diabetes; Exercise; Portion Control; Multiple Chronic Conditions