HealthyMe Online Weight Management Education/HealthyMe at Home

Diabetes Clinical Trial

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Official title:

RCT of Video-Conference & In-Person Weight Loss Services for Adult CHC Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057952
• Other study ID #: 1201007860
• Secondary ID: NIDDK
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Education and exercise
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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Regenstrief Institute, Inc., Wishard Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Change in weight from baseline to 12 months reported in pounds.	Baseline to 12 Months
Primary	Attendance Reported in Minutes	Minutes of participation in study sessions.	12 Months
Primary	Change in Body Weight From Baseline to 6 Months.	Change in body weight from baseline to 6 months.	12 months
Secondary	Change in Short Form 36 Survey Score	The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.	Baseline to 12 Months
Secondary	Change in Systolic Blood Pressure	Systolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months). Negative value indicates decrease in blood pressure.	12 Months
Secondary	Cost-effectiveness	The cost effectiveness ratios were calculated by dividing the difference in total cost per arm by the difference in percent of subjects with 2+ kg weight loss	12 months
Secondary	Change in SF 36 From Baseline to 6 Months	The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.	6 Months
Secondary	Change in Systolic Blood Pressure	Change in pressure from baseline to 6 months	6 Months
Secondary	Change in Diastolic Blood Pressure at 6 Months	Change in pressure from baseline to 6 months	6 Months
Secondary	Change in Diastolic Blood Pressure Baseline to 12 Months	Diastolic blood pressure change from baseline to 12 months. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months; negative value indicates decrease in blood pressure).	12 Months