Trial Outcomes & Findings for Weight Management in Rural Communities (NCT NCT02932748)
NCT ID: NCT02932748
Last Updated: 2024-03-08
Results Overview
Mean weight change (kg) of participants between the three study groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
187 participants
Primary outcome timeframe
Change in baseline to 6 months
Results posted on
2024-03-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
71
|
80
|
36
|
|
Overall Study
COMPLETED
|
47
|
60
|
28
|
|
Overall Study
NOT COMPLETED
|
24
|
20
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Management in Rural Communities
Baseline characteristics by cohort
| Measure |
Group Phone Conference Call
n=71 Participants
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.
|
Individual Phone Call
n=80 Participants
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.
|
Enhanced Usual Care
n=36 Participants
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.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
80 participants
n=7 Participants
|
36 participants
n=5 Participants
|
187 participants
n=4 Participants
|
|
Body Mass Index
|
35.6 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
34.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=7 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
35.1 kg/m^2
STANDARD_DEVIATION 4.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change in baseline to 6 monthsMean weight change (kg) of participants between the three study groups.
Outcome measures
| Measure |
Group Phone Conference Call
n=47 Participants
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.
|
Individual Phone Call
n=60 Participants
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.
|
Enhanced Usual Care
n=28 Participants
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.
|
|---|---|---|---|
|
Mean Weight Change Over 6 Months
|
-11.4 kilograms
Standard Deviation 6.7
|
-9.1 kilograms
Standard Deviation 6.8
|
-2.6 kilograms
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsMean BMI change (kg/m\^2) of participants between the three study groups.
Outcome measures
| Measure |
Group Phone Conference Call
n=47 Participants
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.
|
Individual Phone Call
n=60 Participants
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.
|
Enhanced Usual Care
n=28 Participants
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.
|
|---|---|---|---|
|
Change in BMI Across 6 Months
|
-4.1 kg/m^2
Standard Deviation 2.2
|
-3.2 kg/m^2
Standard Deviation 2.3
|
-0.9 kg/m^2
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Change from baseline - 6 monthsMean waist circumference change (cm) in the three study groups.
Outcome measures
| Measure |
Group Phone Conference Call
n=45 Participants
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.
|
Individual Phone Call
n=60 Participants
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.
|
Enhanced Usual Care
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Waist Circumference Across 6 Months
|
-7.2 cm
Standard Deviation 6.1
|
-6.1 cm
Standard Deviation 5.8
|
-2.1 cm
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
Mean change in fasting triglycerides will be compared across all treatment arms.
Outcome measures
| Measure |
Group Phone Conference Call
n=43 Participants
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.
|
Individual Phone Call
n=53 Participants
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.
|
Enhanced Usual Care
n=26 Participants
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.
|
|---|---|---|---|
|
Triglycerides
|
-26.2 mg/dL
Standard Deviation 39
|
-29.4 mg/dL
Standard Deviation 61.3
|
4.8 mg/dL
Standard Deviation 39.1
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
Mean change in fasting HDL-cholesterol will be compared across all treatment arms.
Outcome measures
| Measure |
Group Phone Conference Call
n=43 Participants
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.
|
Individual Phone Call
n=53 Participants
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.
|
Enhanced Usual Care
n=26 Participants
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.
|
|---|---|---|---|
|
HDL-cholesterol
|
0.3 mg/dL
Standard Deviation 9.6
|
0.3 mg/dL
Standard Deviation 9.6
|
1.6 mg/dL
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsMean change in systolic blood pressure will be compared across all treatment arms.
Outcome measures
| Measure |
Group Phone Conference Call
n=45 Participants
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.
|
Individual Phone Call
n=60 Participants
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.
|
Enhanced Usual Care
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure Across 6 Months
|
-8.6 mmHg
Standard Deviation 13.1
|
-7.9 mmHg
Standard Deviation 13.4
|
1.7 mmHg
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Blood values were missing for n=2 in GP, n=7 in IP and n=2 in EUC.
Mean change in fasting glucose will be compared across all treatment arms.
Outcome measures
| Measure |
Group Phone Conference Call
n=43 Participants
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.
|
Individual Phone Call
n=51 Participants
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.
|
Enhanced Usual Care
n=26 Participants
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.
|
|---|---|---|---|
|
Change in Fasting Glucose Across 6 Months
|
-5.9 mg/dL
Standard Deviation 9.7
|
-4.4 mg/dL
Standard Deviation 26.2
|
1.6 mg/dL
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not collected for the Enhanced Usual Care Arm/Group as this was the comparator.
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.
Outcome measures
| Measure |
Group Phone Conference Call
n=47 Participants
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.
|
Individual Phone Call
n=60 Participants
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.
|
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.
|
|---|---|---|---|
|
Cost Effectiveness at 6 Months
|
60 $/kg
|
93 $/kg
|
—
|
Adverse Events
Group Phone Conference Call
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Phone Call
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group Phone Conference Call
n=71 participants at risk
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.
|
Individual Phone Call
n=80 participants at risk
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.
|
Enhanced Usual Care
n=36 participants at risk
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.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer, breast
|
0.00%
0/71 • 18 months
|
0.00%
0/80 • 18 months
|
2.8%
1/36 • Number of events 1 • 18 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/71 • 18 months
|
1.2%
1/80 • Number of events 1 • 18 months
|
0.00%
0/36 • 18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Anna M. Gorczyca, PhD
University of Kansas Medical Center
Phone: 913-588-9077
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place