Weight Management in Rural Communities — M-DEx  

Obesity Clinical Trial

Official title: Weight Management in Rural Communities

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

• NCT number: NCT02932748
• Study type: Interventional
• Source: University of Kansas
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: October 2021