Midwest Diet and Exercise Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Weight Management in Rural Communities

Conditions
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Weight Loss, Obesity, Body Weight

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Phone Conference Call<br>Delivery: Group Phone Diet: PCMs | Dietary Supplement: Portion Controlled Meals (PCM)<br>* Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.<br>Behavioral: Group Phone (GP)<br>* Weight management program delivered via group conference call.<br>|
| Experimental: Individual Phone Call<br>Delivery: Individual Phone Call Diet: PCMs | Dietary Supplement: Portion Controlled Meals (PCM)<br>* Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.<br>Behavioral: Individual Phone (IP)<br>* Weight management program delivered via individual phone call.<br>|
| Active Comparator: Enhanced Usual Care<br>Delivery: Face-to-Face Diet: Conventional Diet | Dietary Supplement: Conventional Diet<br>* 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.<br>Behavioral: Enhanced Usual Care (EUC)<br>* Weight management topics delivered face-to-face at clinic office every 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 12, 18, and 24 months | 
| Waist circumference |  | 6, 12, and 18 months | 
| Triglycerides |  | 6, 12, and 18 months | 
| HDL-cholesterol |  | 6, 12, and 18 months | 
| Blood pressure |  | 6, 12, and 18 months | 
| Fasting glucose |  | 6, 12, and 18 months | 
| Cost effectiveness (process flow chart) | Cost/kg of weight loss with be assessed and compared among other published interventions. | 6 and 18 months |