Rural Lifestyle Eating and Activity Program (Rural LEAP)

NACompletedINTERVENTIONAL
Enrollment

631

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2018

Study Completion Date

April 30, 2020

Conditions
Obesity
Interventions
BEHAVIORAL

Lifestyle intervention

"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.~Phase 1 will be 4 months of weight loss treatment~Phase 2 will be 12 months of follow-up contact by group telephone call.~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.~During Phase 2 participants will receive two phone calls per month from their group leader for the first 6 months, and one phone call per month for the next 6 months."

BEHAVIORAL

Health education control

"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.~Phase 1 will be 4 months of weight loss treatment~Phase 2 will be 12 months of follow-up contact by email.~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.~During Phase 2 participants will receive a specially prepared newsletter two times per month. The newsletter will contain educational information about proper eating and physical activity. The newsletters will include low-fat and low-calorie recipes, along with tip sheets that describe strategies to help them maintain lost weight."

BEHAVIORAL

Individual

"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.~Phase 1 will be 4 months of weight loss treatment~Phase 2 will be 12 months of follow-up contact by on-on-one telephone call.~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.~During Phase 2 participants will receive two phone calls per month from their group leader for the first 6 months, and one phone call per month for the next 6 months."

BEHAVIORAL

All Groups

All participants will receive the following: Questionnaires, height, weight, waist measurement, blood pressure, heart rate, electrocardiogram, blood sample, urine sample, urine pregnancy test (for females only), 400 meter walking test

Trial Locations (14)

32052

Hamilton County, Jasper

32054

Union County, Lake Butler

32055

Columbia County, Lake City

32063

Baker County, Macclenny

32064

Suwannee County, Live Oak

32066

Lafayette County, Mayo

32091

Bradford County, Starke

32110

Flagler County, Bunnell

32131

Putnam County, Palatka

32340

Madison County, Madison

32348

Taylor County, Perry

32621

Levy County, Bronson

32628

Dixie County, Cross City

32693

Gilchrist County, Trenton

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Florida

OTHER

NCT02054624 - Rural Lifestyle Eating and Activity Program (Rural LEAP) | Biotech Hunter | Biotech Hunter