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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK108732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Phone Conference Call | Experimental | Delivery: Group Phone Diet: PCMs |
|
| Individual Phone Call | Experimental | Delivery: Individual Phone Call Diet: PCMs |
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| Enhanced Usual Care | Active Comparator | Delivery: Face-to-Face Diet: Conventional Diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portion Controlled Meals (PCM) | Dietary Supplement | Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight Change Over 6 Months | Mean weight change (kg) of participants between the three study groups. | Change in baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI Across 6 Months | Mean BMI change (kg/m^2) of participants between the three study groups. | Change from baseline to 6 months |
| Change in Waist Circumference Across 6 Months | Mean waist circumference change (cm) in the three study groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Donnelly, EdD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Energy Balance Lab, The University of Kansas | Lawrence | Kansas | 66045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38660371 | Derived | 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. | |
| 29454140 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Phone Conference Call | Delivery: Group Phone Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Group Phone (GP): Weight management program delivered via group conference call. |
| FG001 | Individual Phone Call | Delivery: Individual Phone Call Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Individual Phone (IP): Weight management program delivered via individual phone call. |
| FG002 | Enhanced Usual Care | Delivery: Face-to-Face Diet: Conventional Diet 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. Enhanced Usual Care (EUC): Weight management topics delivered face-to-face at clinic office every 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Phone Conference Call | Delivery: Group Phone Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Group Phone (GP): Weight management program delivered via group conference call. |
| BG001 | Individual Phone Call |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weight Change Over 6 Months | Mean weight change (kg) of participants between the three study groups. | Posted | Mean | Standard Deviation | kilograms | Change in baseline to 6 months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Phone Conference Call | Delivery: Group Phone Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Group Phone (GP): Weight management program delivered via group conference call. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer, breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna M. Gorczyca, PhD | University of Kansas Medical Center | 913-588-9077 | agorczyca@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2020 | Dec 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
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| 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. |
|
| Change from baseline - 6 months |
| Triglycerides | Mean change in fasting triglycerides will be compared across all treatment arms. | Change from baseline to 6 months |
| HDL-cholesterol | Mean change in fasting HDL-cholesterol will be compared across all treatment arms. | Change from baseline to 6 months |
| Change in Systolic Blood Pressure Across 6 Months | Mean change in systolic blood pressure will be compared across all treatment arms. | Change from baseline to 6 months |
| Change in Fasting Glucose Across 6 Months | Mean change in fasting glucose will be compared across all treatment arms. | Change from baseline to 6 months |
| 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. | 6 months |
Delivery: Individual Phone Call Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Individual Phone (IP): Weight management program delivered via individual phone call. |
| BG002 | Enhanced Usual Care | Delivery: Face-to-Face Diet: Conventional Diet 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. Enhanced Usual Care (EUC): Weight management topics delivered face-to-face at clinic office every 6 months. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Enhanced Usual Care | Delivery: Face-to-Face Diet: Conventional Diet 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. Enhanced Usual Care (EUC): Weight management topics delivered face-to-face at clinic office every 6 months. |
|
|
|
| Secondary | Change in BMI Across 6 Months | Mean BMI change (kg/m^2) of participants between the three study groups. | Posted | Mean | Standard Deviation | kg/m^2 | Change from baseline to 6 months |
|
|
|
| Secondary | Change in Waist Circumference Across 6 Months | Mean waist circumference change (cm) in the three study groups. | Posted | Mean | Standard Deviation | cm | Change from baseline - 6 months |
|
|
|
| Secondary | Triglycerides | Mean change in fasting triglycerides will be compared across all treatment arms. | Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC. | Posted | Mean | Standard Deviation | mg/dL | Change from baseline to 6 months |
|
|
|
| Secondary | HDL-cholesterol | Mean change in fasting HDL-cholesterol will be compared across all treatment arms. | Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC. | Posted | Mean | Standard Deviation | mg/dL | Change from baseline to 6 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure Across 6 Months | Mean change in systolic blood pressure will be compared across all treatment arms. | Posted | Mean | Standard Deviation | mmHg | Change from baseline to 6 months |
|
|
|
| Secondary | Change in Fasting Glucose Across 6 Months | Mean change in fasting glucose will be compared across all treatment arms. | Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC. | Posted | Mean | Standard Deviation | mg/dL | Change from baseline to 6 months |
|
|
|
| Secondary | 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. | Data not collected for the Enhanced Usual Care Arm/Group as this was the comparator. | Posted | Number | $/kg | 6 months |
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| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Individual Phone Call | Delivery: Individual Phone Call Diet: PCMs Portion Controlled Meals (PCM): Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food. Individual Phone (IP): Weight management program delivered via individual phone call. | 0 | 80 | 1 | 80 | 0 | 80 |
| EG002 | Enhanced Usual Care | Delivery: Face-to-Face Diet: Conventional Diet 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. Enhanced Usual Care (EUC): Weight management topics delivered face-to-face at clinic office every 6 months. | 0 | 36 | 1 | 36 | 0 | 36 |
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |