Weight Management in Rural Communities

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-10-31

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.

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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.

Conditions

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Weight Loss Obesity Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group Phone Conference Call

Delivery: Group Phone Diet: PCMs

Group Type EXPERIMENTAL

Portion Controlled Meals (PCM)

Intervention Type DIETARY_SUPPLEMENT

Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Group Phone (GP)

Intervention Type BEHAVIORAL

Weight management program delivered via group conference call.

Individual Phone Call

Delivery: Individual Phone Call Diet: PCMs

Group Type EXPERIMENTAL

Portion Controlled Meals (PCM)

Intervention Type DIETARY_SUPPLEMENT

Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Individual Phone (IP)

Intervention Type BEHAVIORAL

Weight management program delivered via individual phone call.

Enhanced Usual Care

Delivery: Face-to-Face Diet: Conventional Diet

Group Type ACTIVE_COMPARATOR

Conventional Diet

Intervention Type DIETARY_SUPPLEMENT

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.

Enhanced Usual Care (EUC)

Intervention Type BEHAVIORAL

Weight management topics delivered face-to-face at clinic office every 6 months.

Interventions

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Portion Controlled Meals (PCM)

Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Intervention Type DIETARY_SUPPLEMENT

Group Phone (GP)

Weight management program delivered via group conference call.

Intervention Type BEHAVIORAL

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.

Intervention Type DIETARY_SUPPLEMENT

Individual Phone (IP)

Weight management program delivered via individual phone call.

Intervention Type BEHAVIORAL

Enhanced Usual Care (EUC)

Weight management topics delivered face-to-face at clinic office every 6 months.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No