Clinical trial NCT02932748: Weight Management in Rural Communities
Official title: Weight Management in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Body Weight
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-13
Enrollment: 187
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Weight Change Over 6 Months
timeFrame: Change in baseline to 6 months
Secondary outcomes:
measure: Change in BMI Across 6 Months
timeFrame: Change from baseline to 6 months
measure: Change in Waist Circumference Across 6 Months
timeFrame: Change from baseline - 6 months
measure: Triglycerides
timeFrame: Change from baseline to 6 months
measure: HDL-cholesterol
timeFrame: Change from baseline to 6 months
measure: Change in Systolic Blood Pressure Across 6 Months
timeFrame: Change from baseline to 6 months
measure: Change in Fasting Glucose Across 6 Months
timeFrame: Change from baseline to 6 months
measure: Cost Effectiveness at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: Energy Balance Lab, The University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Joseph Donnelly, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.