Weight Management in Rural Communities (M-DEx)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Body Weight; Weight Loss
• Intervention / Treatment: Dietary supplement: Portion Controlled Meals (PCM); Behavioral: Group Phone (GP); Behavioral: Individual Phone (IP); Dietary supplement: Conventional Diet; Behavioral: Enhanced Usual Care (EUC)

Detailed Description

The rates of overweight/obesity are significantly higher among residents of rural areas compared to their urban counterparts. Recent focus to provide whole-person health care suggests that rural primary care clinics may provide an ideal setting for delivery of weight management.

This study is a 3 group randomized trial to evaluate intervention delivery. The investigators will randomize 200 overweight/obese adult residents of rural towns (town population < 50,000) who obtain health care at primary care clinics to one of three groups for an 18 month trial (6 month weight loss; 12 month weight maintenance).

Group 1) Group phone (GP)/Portion-Controlled Meals (PCM)

Group 2) Individual phone (IP)/PCM

Group 3) Enhanced usual care (EUC)/Conventional Diet (CD)

All participants will receive a progressive physical activity program. Physical activity will progress from 45 min/wk in month 1 to 225 min/wk in month 4 and remain at 225 min/wk for the duration of the 18 month study for Group 1 & 2. Physical activity will progress from 45 min/wk in month 1 to 150 min/wk in month 4 and remain at 150 min/wk for the duration of the 18 month study for Group 3.

Participants on the CD will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat (fat= 20-30% energy) diet recommended by the Academy of Nutrition and Dietetics and the USDA's MyPlate approach. Examples of meal plans consisting of suggested servings of proteins, grains, fruits and vegetables, dairy and fats based on individuals energy needs will be provided. Participants using PCM will consume PCMs with the addition of 5 fruits and vegetables per day during weight loss.

EUC will meet with a health educator every 6 months to discuss weight management topics. GP & IP will receive the weight management intervention over the phone weekly during weight loss and biweekly during weight maintenance tracking diet and physical activity and will submit the results to a health educator prior to every meeting.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • Energy Balance Lab, The University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Phone Conference Call; Delivery: Group Phone Diet: PCMs	Dietary supplement: Portion Controlled Meals (PCM); Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.; Behavioral: Group Phone (GP); Weight management program delivered via group conference call.
Experimental: Individual Phone Call; Delivery: Individual Phone Call Diet: PCMs	Dietary supplement: Portion Controlled Meals (PCM); Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.; Behavioral: Individual Phone (IP); Weight management program delivered via individual phone call.
Active Comparator: Enhanced Usual Care; Delivery: Face-to-Face Diet: Conventional Diet	Dietary supplement: Conventional Diet; 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.; Behavioral: Enhanced Usual Care (EUC); Weight management topics delivered face-to-face at clinic office every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Weight Change Over 6 Months	Mean weight change (kg) of participants between the three study groups.	Change in baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI Across 6 Months	Mean BMI change (kg/m^2) of participants between the three study groups.	Change from baseline to 6 months
Change in Waist Circumference Across 6 Months	Mean waist circumference change (cm) in the three study groups.	Change from baseline - 6 months
Triglycerides	Mean change in fasting triglycerides will be compared across all treatment arms.	Change from baseline to 6 months
HDL-cholesterol	Mean change in fasting HDL-cholesterol will be compared across all treatment arms.	Change from baseline to 6 months
Change in Systolic Blood Pressure Across 6 Months	Mean change in systolic blood pressure will be compared across all treatment arms.	Change from baseline to 6 months
Change in Fasting Glucose Across 6 Months	Mean change in fasting glucose will be compared across all treatment arms.	Change from baseline to 6 months
Cost Effectiveness at 6 Months	Cost effectiveness was calculated for the group as the average total cost of the intervention arm (GP or IP) divided by the average weight loss at 6 months of the intervention arm. Costs associated with delivering the 6-month weight loss intervention, including supplies and intervention implementation, were estimated in 2019 U.S. dollars. Supply costs, i.e., pedometers, participant notebooks, providing and shipping low-calorie shakes and printed materials for the GP and IP arms. Implementation costs, i.e., time devoted to interventionist training, preparation and delivery of behavioral sessions and email contacts with participants were estimated as the time spent in these activities obtained from interventionist time sheets multiplied by interventionists hourly wage. Due to the cost effectiveness outcome measure being a ratio between two random variables, there are no dispersion/precision measures reported.	6 months

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Joseph Donnelly, EdD, University of Kansas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimated): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: HSCL03396; R01DK108732 (U.S. NIH Grant/Contract)