Weight Loss, Obesity, Body Weight
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTPortion Controlled Meals (PCM)
Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.
BEHAVIORALGroup Phone (GP)
Weight management program delivered via group conference call.
DIETARY_SUPPLEMENTConventional 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.
BEHAVIORALIndividual Phone (IP)
Weight management program delivered via individual phone call.
BEHAVIORALEnhanced Usual Care (EUC)
Weight management topics delivered face-to-face at clinic office every 6 months.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight Change Over 6 Months | Change in baseline to 6 months | Mean weight change (kg) of participants between the three study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI Across 6 Months | Change from baseline to 6 months | Mean BMI change (kg/m\^2) of participants between the three study groups. |
| Change in Waist Circumference Across 6 Months | Change from baseline - 6 months | Mean waist circumference change (cm) in the three study groups. |
| Triglycerides | Change from baseline to 6 months | Mean change in fasting triglycerides will be compared across all treatment arms. |
| Change in Fasting Glucose Across 6 Months | Change from baseline to 6 months | Mean change in fasting glucose will be compared across all treatment arms. |
| Change in Systolic Blood Pressure Across 6 Months | Change from baseline to 6 months | Mean change in systolic blood pressure will be compared across all treatment arms. |
| Cost Effectiveness at 6 Months | 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. |
| HDL-cholesterol | Change from baseline to 6 months | Mean change in fasting HDL-cholesterol will be compared across all treatment arms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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. | 80 |
| 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. | 36 |
| Total | 187 |
Baseline characteristics
| Characteristic | Group Phone Conference Call | Individual Phone Call | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 14.2 | 49.4 years STANDARD_DEVIATION 11.2 | 50.4 years STANDARD_DEVIATION 13.8 | 50.0 years STANDARD_DEVIATION 12.9 |
| Body Mass Index | 35.6 kg/m^2 STANDARD_DEVIATION 4.7 | 34.6 kg/m^2 STANDARD_DEVIATION 4.5 | 35.2 kg/m^2 STANDARD_DEVIATION 4.5 | 35.1 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 70 Participants | 32 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 9 Participants | 4 Participants | 21 Participants |
| Region of Enrollment United States | 71 participants | 80 participants | 36 participants | 187 participants |
| Sex: Female, Male Female | 59 Participants | 66 Participants | 28 Participants | 153 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 8 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 80 | 0 / 36 |
| other Total, other adverse events | 0 / 71 | 0 / 80 | 0 / 36 |
| serious Total, serious adverse events | 0 / 71 | 1 / 80 | 1 / 36 |
Outcome results
Primary
Mean Weight Change Over 6 Months
Mean weight change (kg) of participants between the three study groups.
Time frame: Change in baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Mean Weight Change Over 6 Months | -11.4 kilograms | Standard Deviation 6.7 |
| Individual Phone Call | Mean Weight Change Over 6 Months | -9.1 kilograms | Standard Deviation 6.8 |
| Enhanced Usual Care | Mean Weight Change Over 6 Months | -2.6 kilograms | Standard Deviation 4.8 |
p-value: <0.0001ANOVA
Secondary
Change in BMI Across 6 Months
Mean BMI change (kg/m\^2) of participants between the three study groups.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Change in BMI Across 6 Months | -4.1 kg/m^2 | Standard Deviation 2.2 |
| Individual Phone Call | Change in BMI Across 6 Months | -3.2 kg/m^2 | Standard Deviation 2.3 |
| Enhanced Usual Care | Change in BMI Across 6 Months | -0.9 kg/m^2 | Standard Deviation 1.6 |
Secondary
Change in Fasting Glucose Across 6 Months
Mean change in fasting glucose will be compared across all treatment arms.
Time frame: Change from baseline to 6 months
Population: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Change in Fasting Glucose Across 6 Months | -5.9 mg/dL | Standard Deviation 9.7 |
| Individual Phone Call | Change in Fasting Glucose Across 6 Months | -4.4 mg/dL | Standard Deviation 26.2 |
| Enhanced Usual Care | Change in Fasting Glucose Across 6 Months | 1.6 mg/dL | Standard Deviation 8.3 |
Secondary
Change in Systolic Blood Pressure Across 6 Months
Mean change in systolic blood pressure will be compared across all treatment arms.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Change in Systolic Blood Pressure Across 6 Months | -8.6 mmHg | Standard Deviation 13.1 |
| Individual Phone Call | Change in Systolic Blood Pressure Across 6 Months | -7.9 mmHg | Standard Deviation 13.4 |
| Enhanced Usual Care | Change in Systolic Blood Pressure Across 6 Months | 1.7 mmHg | Standard Deviation 19.5 |
Secondary
Change in Waist Circumference Across 6 Months
Mean waist circumference change (cm) in the three study groups.
Time frame: Change from baseline - 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Change in Waist Circumference Across 6 Months | -7.2 cm | Standard Deviation 6.1 |
| Individual Phone Call | Change in Waist Circumference Across 6 Months | -6.1 cm | Standard Deviation 5.8 |
| Enhanced Usual Care | Change in Waist Circumference Across 6 Months | -2.1 cm | Standard Deviation 4.5 |
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.
Time frame: 6 months
Population: Data not collected for the Enhanced Usual Care Arm/Group as this was the comparator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group Phone Conference Call | Cost Effectiveness at 6 Months | 60 $/kg |
| Individual Phone Call | Cost Effectiveness at 6 Months | 93 $/kg |
Secondary
HDL-cholesterol
Mean change in fasting HDL-cholesterol will be compared across all treatment arms.
Time frame: Change from baseline to 6 months
Population: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | HDL-cholesterol | 0.3 mg/dL | Standard Deviation 9.6 |
| Individual Phone Call | HDL-cholesterol | 0.3 mg/dL | Standard Deviation 9.6 |
| Enhanced Usual Care | HDL-cholesterol | 1.6 mg/dL | Standard Deviation 6.2 |
Secondary
Triglycerides
Mean change in fasting triglycerides will be compared across all treatment arms.
Time frame: Change from baseline to 6 months
Population: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Phone Conference Call | Triglycerides | -26.2 mg/dL | Standard Deviation 39 |
| Individual Phone Call | Triglycerides | -29.4 mg/dL | Standard Deviation 61.3 |
| Enhanced Usual Care | Triglycerides | 4.8 mg/dL | Standard Deviation 39.1 |