DiabetesHOMENCT02057952
HealthyMe Online Weight Management Education/HealthyMe at Home
A study testing Education and exercise in people with Diabetes, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Education and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46205
About this study
Official title: RCT of Video-Conference & In-Person Weight Loss Services for Adult CHC Patients
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Education and exercise
- Keywords
- Weight Management, Diabetes, Exercise, Portion Control, Multiple Chronic Conditions
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Control | No intervention | No intervention. |
| In Person Weight Management | Active comparator | Education and exercise in a community health center environment. Receives: Behavioral: Education and exercise |
| Video Conference Weight Management | Experimental | Education and exercise delivered through video conference. Receives: Behavioral: Education and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Change in weight from baseline to 12 months reported in pounds.
Measured: Baseline to 12 Months
Attendance Reported in Minutes
Minutes of participation in study sessions.
Measured: 12 Months
Change in Body Weight From Baseline to 6 Months.
Change in body weight from baseline to 6 months.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: Baseline to 12 Months
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.
Measured: 12 Months
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
Measured: 12 months
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.
Measured: 6 Months
Change in Systolic Blood Pressure
Change in pressure from baseline to 6 months
Measured: 6 Months
Change in Diastolic Blood Pressure at 6 Months
Change in pressure from baseline to 6 months
Measured: 6 Months
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).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startApr 2012
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Regenstrief Institute, Inc., Wishard Health Services
- Responsible party
- Principal investigator, Daniel Clark, Indiana University
- Investigators
- Daniel O. Clark, Ph.D, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057952
- Sponsor's protocol ID
- 1201007860
- Other IDs
- NIDDK
- Acronym
- HOME
- Status last verified
- Aug 2018
- First submitted
- 6 Apr 2012
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 Apr;131:109970. doi: 10.1016/j.jpsychores.2020.109970. Epub 2020 Feb 15.
PubMed 32088427
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Video-Conference & In-Person Weight Loss Services for Adult CHC Patients
- ClinicalTrials.gov ID
- NCT02057952
- Acronym / sponsor ID
- HOME / 1201007860
- Conditions
- Diabetes
- Keywords
- Weight Management, Diabetes, Exercise, Portion Control, Multiple Chronic Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Regenstrief Institute, Inc., Wishard Health Services
- Study start
- Apr 2012
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Posted 27 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | No intervention | –No intervention. |
| In Person Weight Management | Active comparator | Behavioral: Education and exerciseEducation and exercise in a community health center environment. |
| Video Conference Weight Management | Experimental | Behavioral: Education and exerciseEducation and exercise delivered through video conference. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and exerciseThe 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. | Behavioural | In Person Weight Management, Video Conference Weight Management |
Primary outcome
Body Weight
Time frame: Baseline to 12 Months
Change in weight from baseline to 12 months reported in pounds.
Attendance Reported in Minutes
Time frame: 12 Months
Minutes of participation in study sessions.
Change in Body Weight From Baseline to 6 Months.
Time frame: 12 months
Change in body weight from baseline to 6 months.
7 secondary outcomes
Change in Short Form 36 Survey Score
Time frame: Baseline to 12 Months
Change in Systolic Blood Pressure
Time frame: 12 Months
Cost-effectiveness
Time frame: 12 months
Change in SF 36 From Baseline to 6 Months
Time frame: 6 Months
Change in Systolic Blood Pressure
Time frame: 6 Months
Change in Diastolic Blood Pressure at 6 Months
Time frame: 6 Months
Change in Diastolic Blood Pressure Baseline to 12 Months
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32088427Shell 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 Apr;131:109970. doi: 10.1016/j.jpsychores.2020.109970. Epub 2020 Feb 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel O. Clark, Ph.D principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and exercise in people with Diabetes, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline to 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02057952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.