Weight Management in Rural Communities

NCT02932748 | Completed Results DMC

• 2 other identifiers: HSCL03396R01DK108732
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effect of three weight management interventions (group phone conference calls, individual phone calls, and enhanced usual care) on weight across 18 months in overweight and obese adults recruited through and treated by rural primary care clinics.

Conditions

Weight Loss; Obesity; Body Weight

Outcome Measures

Primary Outcomes (1)

• Mean Weight Change Over 6 Months

  Mean weight change (kg) of participants between the three study groups.

  Change in baseline to 6 months

Secondary Outcomes (7)

• Change in BMI Across 6 Months

  Change from baseline to 6 months

• Change in Waist Circumference Across 6 Months

  Change from baseline - 6 months

• Triglycerides

  Change from baseline to 6 months

• HDL-cholesterol

  Change from baseline to 6 months

• Change in Systolic Blood Pressure Across 6 Months

  Change from baseline to 6 months

Study Arms (3)

Group Phone Conference Call

EXPERIMENTAL

Delivery: Group Phone Diet: PCMs

Dietary Supplement: Portion Controlled Meals (PCM); Behavioral: Group Phone (GP)

Individual Phone Call

EXPERIMENTAL

Delivery: Individual Phone Call Diet: PCMs

Dietary Supplement: Portion Controlled Meals (PCM); Behavioral: Individual Phone (IP)

Enhanced Usual Care

ACTIVE COMPARATOR

Delivery: Face-to-Face Diet: Conventional Diet

Dietary Supplement: Conventional Diet; Behavioral: Enhanced Usual Care (EUC)

Interventions

Portion Controlled Meals (PCM) DIETARY_SUPPLEMENT

Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Group Phone Conference Call; Individual Phone Call

Group Phone (GP) BEHAVIORAL

Weight management program delivered via group conference call.

Group Phone Conference Call

Conventional Diet DIETARY_SUPPLEMENT

Conventional diet (CD) will consist of a nutritionally balanced, reduced energy, high volume, lower fat (fat= 20-30% energy) diet based on USDA's MyPlate recommendations.

Enhanced Usual Care

Individual Phone (IP) BEHAVIORAL

Weight management program delivered via individual phone call.

Individual Phone Call

Enhanced Usual Care (EUC) BEHAVIORAL

Weight management topics delivered face-to-face at clinic office every 6 months.

Enhanced Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 25 to 45 kg/m2
• Clearance from primary care physician

You may not qualify if:

• Unable to participate in moderate intensity physical activity
• Participation in weight loss or physical activity program in previous 6 months
• Greater than 3, 30-min bouts of planned exercise/week
• Not weight stable (+/-4.6 kg) for 3 months prior to intake
• Unwilling to be randomized to 1 of the 3 study groups
• Report being pregnant during the previous 6 months or planned pregnancy in the following 18 months
• Serious medical risk such as cancer, recent cardiac event
• Current use of antipsychotics or untreated depression
• Adherence to specialized diet regimens (food allergy, vegetarian, macrobiotic)
• Binge eating disorder
• Planning to movie to a location and no longer having access to rural clinic site

Sponsors & Collaborators

• University of Kansas: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (2)

• Gorczyca AM, Washburn RA, Ptomey LT, Mayo MS, Krebill R, Sullivan DK, Gibson CA, Stolte S, Donnelly JE. Weight management in rural health clinics: Results from the randomized midwest diet and exercise trial. Obes Sci Pract. 2024 Apr 24;10(2):e753. doi: 10.1002/osp4.753. eCollection 2024 Apr.

  PMID: 38660371 DERIVED

• Gorczyca AM, Washburn RA, Ptomey L, Mayo MS, Sullivan DK, Gibson CA, Lee R, Stolte S, Donnelly JE. Weight management in rural health clinics: The Midwest diet and exercise trial. Contemp Clin Trials. 2018 Apr;67:37-46. doi: 10.1016/j.cct.2018.02.006. Epub 2018 Feb 15.

  PMID: 29454140 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Anna M. Gorczyca, PhD
• Organization: University of Kansas Medical Center

agorczyca@kumc.edu

913-588-9077

Study Officials

• Joseph Donnelly, EdD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 13, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2021
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Locations

US (1)