N/A N=187 Randomized Treatment

Weight Management in Rural Communities

Weight Loss · Obesity · Body Weight

Bottom Line

View on ClinicalTrials.gov: NCT02932748 ↗

Enrolled (actual)

187

Serious AEs

1.1%

Results posted

Mar 2024

Primary outcome: Primary: Mean Weight Change Over 6 Months — -11.4; -9.1; -2.6 kilograms — p=<.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Portion Controlled Meals (PCM) (Dietary_supplement); Group Phone (GP) (Behavioral); Conventional Diet (Dietary_supplement); Individual Phone (IP) (Behavioral); Enhanced Usual Care (EUC) (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Kansas
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Weight Change Over 6 Months	-11.4; -9.1; -2.6	<.0001 sig
SECONDARY Change in BMI Across 6 Months	-4.1; -3.2; -0.9	—
SECONDARY Change in Waist Circumference Across 6 Months	-7.2; -6.1; -2.1	—
SECONDARY Triglycerides	-26.2; -29.4; 4.8	—
SECONDARY HDL-cholesterol	0.3; 0.3; 1.6	—
SECONDARY Change in Systolic Blood Pressure Across 6 Months	-8.6; -7.9; 1.7	—
SECONDARY Change in Fasting Glucose Across 6 Months	-5.9; -4.4; 1.6	—
SECONDARY Cost Effectiveness at 6 Months	60; 93	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02932748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.