Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
200

Summary

Conditions
  • Body Weight
  • Obesity
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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 gr...

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.

Tracking Information

NCT #
NCT02932748
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Joseph Donnelly, EdD University of Kansas