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HealthyMe Online Weight Management Education/HealthyMe at Home

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02057952
Acronym
HOME
Enrollment
150
Registered
2014-02-07
Start date
2012-04-30
Completion date
2018-03-31
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Weight Management, Diabetes, Exercise, Portion Control, Multiple Chronic Conditions

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.

Interventions

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.

Sponsors

Regenstrief Institute, Inc.
CollaboratorOTHER
Wishard Health Services
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body WeightBaseline to 12 MonthsChange in weight from baseline to 12 months reported in pounds.
Attendance Reported in Minutes12 MonthsMinutes of participation in study sessions.
Change in Body Weight From Baseline to 6 Months.12 monthsChange in body weight from baseline to 6 months.

Secondary

MeasureTime frameDescription
Change in SF 36 From Baseline to 6 Months6 MonthsThe 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.
Change in Short Form 36 Survey ScoreBaseline to 12 MonthsThe 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.
Change in Diastolic Blood Pressure Baseline to 12 Months12 MonthsDiastolic 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).
Change in Diastolic Blood Pressure at 6 Months6 MonthsChange in pressure from baseline to 6 months
Change in Systolic Blood Pressure12 MonthsSystolic 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.
Cost-effectiveness12 monthsThe 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care Control
No intervention.
51
In Person Weight Management
Education and exercise in a community health center environment. 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.
49
Video Conference Weight Management
Education and exercise delivered through video conference. 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.
50
Total150

Baseline characteristics

CharacteristicUsual Care ControlIn Person Weight ManagementVideo Conference Weight ManagementTotal
Age, Continuous53.9 YEAR OF AGE
STANDARD_DEVIATION 6.1
53.2 YEAR OF AGE
STANDARD_DEVIATION 8.1
53.2 YEAR OF AGE
STANDARD_DEVIATION 6.1
53.4 YEAR OF AGE
STANDARD_DEVIATION 6.8
body mass index, continuous39.4 kilograms divided by meters squared
STANDARD_DEVIATION 6.2
38.9 kilograms divided by meters squared
STANDARD_DEVIATION 5.8
38.5 kilograms divided by meters squared
STANDARD_DEVIATION 5.5
38.9 kilograms divided by meters squared
STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
49 Participants49 Participants50 Participants148 Participants
Patient Health Questionnaire (range 0 [best] -27[worst]), continuous7.6 standardized score
STANDARD_DEVIATION 6
6.9 standardized score
STANDARD_DEVIATION 5.5
7.3 standardized score
STANDARD_DEVIATION 5.3
7.3 standardized score
STANDARD_DEVIATION 5.6
Region of Enrollment
United States
51 participants49 participants50 participants150 participants
Sex: Female, Male
Female
39 Participants38 Participants46 Participants123 Participants
Sex: Female, Male
Male
12 Participants11 Participants4 Participants27 Participants
Short Form 36 (RANGE 0 [Worst] -100 [Best]), continuous52.8 standardized score
STANDARD_DEVIATION 19
59.2 standardized score
STANDARD_DEVIATION 18.4
56.5 standardized score
STANDARD_DEVIATION 21.8
56.1 standardized score
STANDARD_DEVIATION 19.8
weight, continuous236.4 pounds
STANDARD_DEVIATION 43.6
234.1 pounds
STANDARD_DEVIATION 46.7
227.6 pounds
STANDARD_DEVIATION 35.5
232.7 pounds
STANDARD_DEVIATION 42
Years of Education, continuous13.2 Years
STANDARD_DEVIATION 2.4
13.6 Years
STANDARD_DEVIATION 2.4
12.6 Years
STANDARD_DEVIATION 1.7
13.1 Years
STANDARD_DEVIATION 2.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 510 / 490 / 50
other
Total, other adverse events
0 / 510 / 490 / 50
serious
Total, serious adverse events
0 / 510 / 490 / 50

Outcome results

Primary

Attendance Reported in Minutes

Minutes of participation in study sessions.

Time frame: 12 Months

Population: Usual care participants didn't have access to the experimental treatments. In person and video conference arm participants were all eligible for participation.

ArmMeasureValue (MEDIAN)
In Person Weight ManagementAttendance Reported in Minutes0 minutes
Video Conference Weight ManagementAttendance Reported in Minutes90 minutes
Primary

Body Weight

Change in weight from baseline to 12 months reported in pounds.

Time frame: Baseline to 12 Months

Population: The number of participants analyzed is based on the number of participants who completed weight data at baseline and 12 months.

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlBody Weight-0.8 poundsStandard Deviation 10.9
In Person Weight ManagementBody Weight-1.5 poundsStandard Deviation 14.6
Video Conference Weight ManagementBody Weight-7.3 poundsStandard Deviation 11.5
Primary

Change in Body Weight From Baseline to 6 Months.

Change in body weight from baseline to 6 months.

Time frame: 12 months

Population: Analysis are based on number of participants with complete weight data at baseline and 6 months.

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Body Weight From Baseline to 6 Months.1.3 poundsStandard Deviation 9.8
In Person Weight ManagementChange in Body Weight From Baseline to 6 Months.-0.9 poundsStandard Deviation 10.7
Video Conference Weight ManagementChange in Body Weight From Baseline to 6 Months.3.1 poundsStandard Deviation 9.2
Secondary

Change in Diastolic Blood Pressure at 6 Months

Change in pressure from baseline to 6 months

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Diastolic Blood Pressure at 6 Months1.8 mmHgStandard Deviation 10.4
In Person Weight ManagementChange in Diastolic Blood Pressure at 6 Months0 mmHgStandard Deviation 12.5
Video Conference Weight ManagementChange in Diastolic Blood Pressure at 6 Months6.0 mmHgStandard Deviation 19.7
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).

Time frame: 12 Months

Population: Participants who completed 12 month follow-up

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Diastolic Blood Pressure Baseline to 12 Months-5.8 mmHgStandard Deviation 11.4
In Person Weight ManagementChange in Diastolic Blood Pressure Baseline to 12 Months-2.6 mmHgStandard Deviation 11.8
Video Conference Weight ManagementChange in Diastolic Blood Pressure Baseline to 12 Months-8.1 mmHgStandard Deviation 20.2
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.

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in SF 36 From Baseline to 6 Months3.5 units on a scaleStandard Deviation 15.6
In Person Weight ManagementChange in SF 36 From Baseline to 6 Months-1.1 units on a scaleStandard Deviation 13.5
Video Conference Weight ManagementChange in SF 36 From Baseline to 6 Months6.1 units on a scaleStandard Deviation 13.6
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.

Time frame: Baseline to 12 Months

Population: The analysis of change based on participants with complete Short Form 36 (SF36) scores at baseline and 12 months.

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Short Form 36 Survey Score6.5 score on scaleStandard Deviation 8.7
In Person Weight ManagementChange in Short Form 36 Survey Score-3.1 score on scaleStandard Deviation 18.3
Video Conference Weight ManagementChange in Short Form 36 Survey Score7.1 score on scaleStandard Deviation 19.6
Secondary

Change in Systolic Blood Pressure

Change in pressure from baseline to 6 months

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Systolic Blood Pressure2.5 mmHgStandard Deviation 15.1
In Person Weight ManagementChange in Systolic Blood Pressure-0.8 mmHgStandard Deviation 18.9
Video Conference Weight ManagementChange in Systolic Blood Pressure7.4 mmHgStandard Deviation 20.5
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.

Time frame: 12 Months

Population: Participants who completed 12 month follow-up

ArmMeasureValue (MEAN)Dispersion
Usual Care ControlChange in Systolic Blood Pressure-3.8 mmHgStandard Deviation 14.6
In Person Weight ManagementChange in Systolic Blood Pressure-1.1 mmHgStandard Deviation 17.2
Video Conference Weight ManagementChange in Systolic Blood Pressure-7.4 mmHgStandard Deviation 19.8
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

Time frame: 12 months

ArmMeasureValue (NUMBER)
Usual Care ControlCost-effectiveness0 Total Cost / 100 participants
In Person Weight ManagementCost-effectiveness5564 Total Cost / 100 participants
Video Conference Weight ManagementCost-effectiveness3744 Total Cost / 100 participants

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026