Weight Management in Rural Communities

Not Applicable

Completed

Conditions: Weight Loss
Obesity
Body Weight

Interventions: Dietary Supplement: Portion Controlled Meals (PCM)
Dietary Supplement: Conventional Diet
Behavioral: Group Phone (GP)
Behavioral: Individual Phone (IP)
Behavioral: Enhanced Usual Care (EUC)

Registration Number: NCT02932748

Lead Sponsor: University of Kansas

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 187

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Phone Conference Call	Portion Controlled Meals (PCM)	Delivery: Group Phone Diet: PCMs
Individual Phone Call	Portion Controlled Meals (PCM)	Delivery: Individual Phone Call Diet: PCMs
Enhanced Usual Care	Conventional Diet	Delivery: Face-to-Face Diet: Conventional Diet
Group Phone Conference Call	Group Phone (GP)	Delivery: Group Phone Diet: PCMs
Individual Phone Call	Individual Phone (IP)	Delivery: Individual Phone Call Diet: PCMs
Enhanced Usual Care	Enhanced Usual Care (EUC)	Delivery: Face-to-Face Diet: Conventional Diet

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in BMI Across 6 Months	Change from baseline to 6 months	Mean BMI change (kg/m\^2) of participants between the three study groups.
Change in Waist Circumference Across 6 Months	Change from baseline - 6 months	Mean waist circumference change (cm) in the three study groups.
Triglycerides	Change from baseline to 6 months	Mean change in fasting triglycerides will be compared across all treatment arms.
Change in Systolic Blood Pressure Across 6 Months	Change from baseline to 6 months	Mean change in systolic blood pressure will be compared across all treatment arms.
HDL-cholesterol	Change from baseline to 6 months	Mean change in fasting HDL-cholesterol will be compared across all treatment arms.
Change in Fasting Glucose Across 6 Months	Change from baseline to 6 months	Mean change in fasting glucose will be compared across all treatment arms.
Cost Effectiveness at 6 Months	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.