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Completed

NCT Number: NCT02932748

Weight Management in Rural Communities

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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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portion Controlled Meals (PCM)

Dietary Supplement

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

Group Phone (GP)

Behavioral

Weight management program delivered via group conference call.

Conventional diet

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.

Individual Phone (IP)

Behavioral

Weight management program delivered via individual phone call.

enhanced usual care (EUC)

Behavioral

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

Primary outcomes

  1. Mean Weight Change Over 6 Months

    Time frame: Change in baseline to 6 months

    Mean weight change (kg) of participants between the three study groups.

Secondary outcomes

  1. Change in BMI Across 6 Months

    Time frame: Change from baseline to 6 months

    Mean BMI change (kg/m^2) of participants between the three study groups.

  2. Change in Waist Circumference Across 6 Months

    Time frame: Change from baseline - 6 months

    Mean waist circumference change (cm) in the three study groups.

  3. Triglycerides

    Time frame: Change from baseline to 6 months

    Mean change in fasting triglycerides will be compared across all treatment arms.

  4. HDL-cholesterol

    Time frame: Change from baseline to 6 months

    Mean change in fasting HDL-cholesterol will be compared across all treatment arms.

  5. Change in Systolic Blood Pressure Across 6 Months

    Time frame: Change from baseline to 6 months

    Mean change in systolic blood pressure will be compared across all treatment arms.

  6. Change in Fasting Glucose Across 6 Months

    Time frame: Change from baseline to 6 months

    Mean change in fasting glucose will be compared across all treatment arms.

  7. Cost Effectiveness at 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: M-DEx

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 13, 2016
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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