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HealthyMe Online Weight Management Education/HealthyMe at Home (HOME)

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ClinicalTrials.gov Identifier: NCT02057952
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : October 27, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Regenstrief Institute, Inc.
Wishard Health Services
Information provided by (Responsible Party):
Daniel Clark, Indiana University

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Education and exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of Video-Conference & In-Person Weight Loss Services for Adult CHC Patients
Study Start Date : April 2012
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care Control
No intervention.
Active Comparator: In Person Weight Management
Education and exercise in a community health center environment.
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.

Experimental: Video Conference Weight Management
Education and exercise delivered through video conference.
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.




Primary Outcome Measures :
  1. Body Weight [ Time Frame: Baseline to 12 Months ]
    Change in weight from baseline to 12 months reported in pounds.

  2. Attendance Reported in Minutes [ Time Frame: 12 Months ]
    Minutes of participation in study sessions.

  3. Change in Body Weight From Baseline to 6 Months. [ Time Frame: 12 months ]
    Change in body weight from baseline to 6 months.


Secondary Outcome Measures :
  1. Change in Short Form 36 Survey Score [ Time Frame: Baseline to 12 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.

  2. Change in Systolic Blood Pressure [ Time Frame: 12 Months ]
    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.

  3. Cost-effectiveness [ Time Frame: 12 months ]
    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

  4. Change in SF 36 From Baseline to 6 Months [ Time Frame: 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.

  5. Change in Systolic Blood Pressure [ Time Frame: 6 Months ]
    Change in pressure from baseline to 6 months

  6. Change in Diastolic Blood Pressure at 6 Months [ Time Frame: 6 Months ]
    Change in pressure from baseline to 6 months

  7. Change in Diastolic Blood Pressure Baseline to 12 Months [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057952


Locations
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United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46205
Sponsors and Collaborators
Indiana University
Regenstrief Institute, Inc.
Wishard Health Services
Investigators
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Principal Investigator: Daniel O. Clark, Ph.D Indiana University School of Medicine
  Study Documents (Full-Text)

Documents provided by Daniel Clark, Indiana University:
Study Protocol  [PDF] August 13, 2015
Statistical Analysis Plan  [PDF] August 13, 2015
Informed Consent Form  [PDF] August 24, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Clark, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT02057952    
Other Study ID Numbers: 1201007860
NIDDK ( Other Grant/Funding Number: DK092377 )
First Posted: February 7, 2014    Key Record Dates
Results First Posted: October 27, 2017
Last Update Posted: September 5, 2018
Last Verified: August 2018
Keywords provided by Daniel Clark, Indiana University:
Weight Management
Diabetes
Exercise
Portion Control
Multiple Chronic Conditions