Rural Lifestyle Eating and Activity Program (Rural LEAP)

Summary

The purpose of this research study is to learn about ways to help adults with obesity from rural areas manage their weight and increase their physical activity. An important goal of the study is to find out what type of follow-up program for weight management is necessary to help adults with obesity keep from regaining lost weight. The study will also look at the ways that long-term weight-loss treatments affect blood pressure, blood fats (lipids), blood sugar, and physical fitness.

The participant are being asked to be in this research study because increased weight and obesity are major health problems in the United States. The participant's weight and height fall in the obese category. Adults with obesity have an increased risk of developing health problems such as high blood pressure, diabetes, and heart disease. The rates of being overweight and obese are higher in rural areas of the United States than in urban and suburban areas of the country.

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Florida

  lead OTHER

Principal Investigators

• Michael G Perri, Ph.D., ABPP · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2018-12-31

Completion

2020-04-30

Countries

• United States

Study Locations