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Midwest Diet and Exercise Trial (M-DEx)

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ClinicalTrials.gov Identifier: NCT02932748
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Weight Loss Obesity Body Weight Dietary Supplement: Portion Controlled Meals (PCM) Behavioral: Group Phone (GP) Dietary Supplement: Conventional Diet Behavioral: Individual Phone (IP) Behavioral: Enhanced Usual Care (EUC) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight Management in Rural Communities
Study Start Date : January 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Group Phone Conference Call
Delivery: Group Phone Diet: PCMs
Dietary Supplement: Portion Controlled Meals (PCM)
Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Behavioral: Group Phone (GP)
Weight management program delivered via group conference call.

Experimental: Individual Phone Call
Delivery: Individual Phone Call Diet: PCMs
Dietary Supplement: Portion Controlled Meals (PCM)
Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.

Behavioral: Individual Phone (IP)
Weight management program delivered via individual phone call.

Active Comparator: Enhanced Usual Care
Delivery: Face-to-Face Diet: Conventional Diet
Dietary Supplement: 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.

Behavioral: Enhanced Usual Care (EUC)
Weight management topics delivered face-to-face at clinic office every 6 months.




Primary Outcome Measures :
  1. Weight [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Weight [ Time Frame: 12, 18, and 24 months ]
  2. Waist circumference [ Time Frame: 6, 12, and 18 months ]
  3. Triglycerides [ Time Frame: 6, 12, and 18 months ]
  4. HDL-cholesterol [ Time Frame: 6, 12, and 18 months ]
  5. Blood pressure [ Time Frame: 6, 12, and 18 months ]
  6. Fasting glucose [ Time Frame: 6, 12, and 18 months ]
  7. Cost effectiveness (process flow chart) [ Time Frame: 6 and 18 months ]
    Cost/kg of weight loss with be assessed and compared among other published interventions.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932748


Contacts
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Contact: Anna M Gorczyca, PhD 785-813-6595 mdex@ku.edu

Locations
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United States, Kansas
Energy Balance Lab, The University of Kansas Recruiting
Lawrence, Kansas, United States, 66045
Contact: Joseph Donnelly, EdD    785-864-0797    jdonnelly@ku.edu   
Principal Investigator: Joseph Donnelly, EdD         
Sponsors and Collaborators
University of Kansas
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Joseph Donnelly, EdD University of Kansas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT02932748     History of Changes
Other Study ID Numbers: HSCL03396
R01DK108732 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes