HealthyMe Online Weight Management Education/HealthyMe at Home

NCT02057952 | Completed Results

• 2 other identifiers: 1201007860NIDDK
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Body Weight

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

  Baseline to 12 Months

• Attendance Reported in Minutes

  Minutes of participation in study sessions.

  12 Months

• Change in Body Weight From Baseline to 6 Months.

  Change in body weight from baseline to 6 months.

  12 months

Secondary Outcomes (7)

• Change in Short Form 36 Survey Score

  Baseline to 12 Months

• Change in Systolic Blood Pressure

  12 Months

• Cost-effectiveness

  12 months

• Change in SF 36 From Baseline to 6 Months

  6 Months

• Change in Systolic Blood Pressure

  6 Months

Study Arms (3)

Usual Care Control

NO INTERVENTION

No intervention.

In Person Weight Management

ACTIVE COMPARATOR

Education and exercise in a community health center environment.

Behavioral: Education and exercise

Video Conference Weight Management

EXPERIMENTAL

Education and exercise delivered through video conference.

Behavioral: Education and exercise

Interventions

Education and exercise BEHAVIORAL

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.

In Person Weight Management; Video Conference Weight Management

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Regenstrief Institute, Inc.: collaborator
• Wishard Health Services: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46205, United States

Location

Related Publications (1)

• 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.

  PMID: 32088427 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity; Multiple Chronic Conditions

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Daniel O. Clark, PhD
• Organization: Regenstried Institute

daniclar@iu.edu

317-274-9292

Study Officials

• Daniel O. Clark, Ph.D

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: February 7, 2014
• Study Start: April 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 5, 2018
• Results First Posted: October 27, 2017

Record last verified: 2018-08

Locations

US (1)