NCT02932748

Weight Management in Rural Communities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Weight Loss
• Obesity
• Body Weight

Interventions

Type	Name	Description
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.
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	Individual Phone (IP)	Weight management program delivered via individual phone call.
BEHAVIORAL	Enhanced Usual Care (EUC)	Weight management topics delivered face-to-face at clinic office every 6 months.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-04-01
• Completion: 2021-10-01
• First posted: 2016-10-13
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

1 site across 1 country: United States