Clinical trial NCT02057952: HealthyMe Online Weight Management Education/HealthyMe at Home
Official title: RCT of Video-Conference & In-Person Weight Loss Services for Adult CHC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Weight Management
Diabetes
Exercise
Portion Control
Multiple Chronic Conditions
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Regenstrief Institute, Inc.
name: Wishard Health Services
First posted: 2014-02-07
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* One or more community health visits in the past 12 months
* Body mass index (BMI) of ≥30\<50
* English Speaking
* Access to a telephone
* A residence
* Willingness to be randomized
* Willingness to have a computer installed in the home
* Weight loss referral from CHC provider

Exclusion Criteria:

* Current diagnosis of type 2 diabetes
* Current treatment for cancer
* Current diagnosis of psychosis or bipolar disorder
* Illness that might be associated with weight change, such as asthma, (because of treatment with corticosteroids), psychosis
* Use of medications that might cause weight gain or loss such as hypoglycemic oral medicines or insulin, corticosteroids, some anti-depressants, weight loss medications
* Unwilling or unable to provide informed consent
* Receiving disability insurance
* Pregnant or nursing in the past six months, or plans to become so within 12 months
* Residence outside of Marion County, Indiana
* Residence relocation plans within 12 months
* Enrolled in weight loss program within past 6 months
* Meeting physical activity guidelines
* Planned or prior bariatric surgery
* Substance abuse
* History of treatment for eating disorder
* Unstable weight gain or loss of ≥5% in the last 3 months

Primary outcomes:
measure: Body Weight
timeFrame: Baseline to 12 Months
measure: Attendance Reported in Minutes
timeFrame: 12 Months
measure: Change in Body Weight From Baseline to 6 Months.
timeFrame: 12 months
Secondary outcomes:
measure: Change in Short Form 36 Survey Score
timeFrame: Baseline to 12 Months
measure: Change in Systolic Blood Pressure
timeFrame: 12 Months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Change in SF 36 From Baseline to 6 Months
timeFrame: 6 Months
measure: Change in Systolic Blood Pressure
timeFrame: 6 Months
measure: Change in Diastolic Blood Pressure at 6 Months
timeFrame: 6 Months
measure: Change in Diastolic Blood Pressure Baseline to 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Daniel O. Clark, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shell AL, Hsueh L, Vrany EA, Clark DO, Keith NR, Xu H, Stewart JC. Depressive symptom severity as a predictor of attendance in the HOME behavioral weight loss trial. J Psychosom Res. 2020 Feb 15;131:109970. doi: 10.1016/j.jpsychores.2020.109970. Online ahead of print.