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Weight LossM-DExNCT02932748

Weight Management in Rural Communities

A study testing Group Phone (GP), Conventional Diet and Individual Phone (IP) in people with Weight Loss and Obesity, run by University of Kansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Weight Loss, Obesity, Body Weight
What is being tested?
Group Phone (GP), Conventional Diet and Individual Phone (IP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
1 siteUnited States
Study dates
Jan 2017to Oct 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body mass index 25 to 45 kg/m2
  • Clearance from primary care physician

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Energy Balance Lab, The University of Kansas

    Lawrence, Kansas, 66045

Other trials in United States

About this study

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.

Read the 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.

Being tested
Portion Controlled Meals (PCM), Group Phone (GP), Conventional Diet, Individual Phone (IP), Enhanced Usual Care (EUC)
Medical subject headings
Weight Loss, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portion Controlled Meals (PCM)Dietary supplement

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

  • Group Phone (GP)Behavioural

    Weight management program delivered via group conference call.

  • Conventional DietDietary 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)Behavioural

    Weight management program delivered via individual phone call.

  • Enhanced Usual Care (EUC)Behavioural

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

Study groups in NCT02932748
Study groupRoleWhat they receive
Group Phone Conference CallExperimentalDelivery: Group Phone Diet: PCMs
Receives: Dietary Supplement: Portion Controlled Meals (PCM); Behavioral: Group Phone (GP)
Individual Phone CallExperimentalDelivery: Individual Phone Call Diet: PCMs
Receives: Dietary Supplement: Portion Controlled Meals (PCM); Behavioral: Individual Phone (IP)
Enhanced Usual CareActive comparatorDelivery: Face-to-Face Diet: Conventional Diet
Receives: Dietary Supplement: Conventional Diet; Behavioral: Enhanced Usual Care (EUC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Weight Change Over 6 Months

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

    Measured: Change in baseline to 6 months

Secondary outcomes (7)

  1. Change in BMI Across 6 Months

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

    Measured: Change from baseline to 6 months

  2. Change in Waist Circumference Across 6 Months

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

    Measured: Change from baseline - 6 months

  3. Triglycerides

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

    Measured: Change from baseline to 6 months

  4. HDL-cholesterol

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

    Measured: Change from baseline to 6 months

  5. Change in Systolic Blood Pressure Across 6 Months

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

    Measured: Change from baseline to 6 months

  6. Change in Fasting Glucose Across 6 Months

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

    Measured: Change from baseline to 6 months

  7. Cost Effectiveness at 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionApr 2020
  4. Study completionOct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932748
Sponsor's protocol ID
HSCL03396
Other IDs
R01DK108732
Acronym
M-DEx
Status last verified
Mar 2024
First submitted
14 Sep 2016
Last updated
8 Mar 2024
Data monitoring committee
Yes

Publications

  • Gorczyca AM, Washburn RA, Ptomey LT, Mayo MS, Krebill R, Sullivan DK, Gibson CA, Stolte S, Donnelly JE. Weight management in rural health clinics: Results from the randomized midwest diet and exercise trial. Obes Sci Pract. 2024 Apr 24;10(2):e753. doi: 10.1002/osp4.753. eCollection 2024 Apr.

    PubMed 38660371

  • 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.

    PubMed 29454140

Questions about this trial

What is this clinical trial studying?

A study testing Group Phone (GP), Conventional Diet and Individual Phone (IP) in people with Weight Loss and Obesity, run by University of Kansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Weight Change Over 6 Months (time frame: Change in baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932748, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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