Rural Lifestyle Eating and Activity Program (Rural LEAP)

NCT02054624 | Completed DMC

• 3 other identifiers: 29-2013-NR18HL112720IRB201600055
• Study Type: interventional
• Target: 631
• Locations: 1 country
• Sites: 14

Brief 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

Keywords

Obesity; Rural Health; Exercise; Weight loss; Behavior change

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg) from month 4 to month 22

  Weight is measured on a Tanita digital scale.

  Change from month 4 to month 22

Secondary Outcomes (2)

• Percent of participants achieving 5% or greater weight losses at month 22

  Baseline to month 22

• Percent of participants achieving 10% or greater weight losses at month 22

  Baseline to month 22

Other Outcomes (26)

• Blood pressure (mmHg) from baseline to month 4

  Change from baseline to month 4

• LDL-Cholesterol (mg/dL) change in baseline to month 4

  Change from baseline to month 4

• HDL-Cholesterol (mg/dL) change in baseline to month 4

  Change from baseline to month 4

Study Arms (3)

Individual

ACTIVE COMPARATOR

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 one-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: Individual; Behavioral: All Groups

Lifestyle intervention

ACTIVE COMPARATOR

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 conference 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: Lifestyle intervention; Behavioral: All Groups

Health Education Control

ACTIVE COMPARATOR

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: Health education control; Behavioral: All Groups

Interventions

Lifestyle intervention BEHAVIORAL

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.

Lifestyle intervention

Health education control BEHAVIORAL

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.

Health Education Control

Individual BEHAVIORAL

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.

Individual

All Groups BEHAVIORAL

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

Health Education Control; Individual; Lifestyle intervention

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 21 to 75 years
• Body Mass Index: 30 to 45 kg/m\*\*2

You may not qualify if:

• Underlying disease likely to limit lifespan and/or increase risk of interventions:cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV, self-reported tuberculosis or treatment); myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; irritable bowel syndrome; previous bariatric surgery; history of organ transplantation; history of musculoskeletal conditions that limit walking; chronic lung diseases that limit physical activity; and any other condition likely to limit five-year life expectancy.
• Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling to travel to Extension office for intervention sessions; participation in another randomized research project; weight loss \> 10 pounds in past six months; likely to move out of the county in next two years; major psychiatric disorder; excessive alcohol intake; BMI \> 45; prior participation in the TOURS trial; and other conditions which in the opinion of staff would adversely affect participation in the trial

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (14)

Levy County

Bronson, Florida, 32621, United States

Location

Flagler County

Bunnell, Florida, 32110, United States

Location

Dixie County

Cross City, Florida, 32628, United States

Location

Hamilton County

Jasper, Florida, 32052, United States

Location

Union County

Lake Butler, Florida, 32054, United States

Location

Columbia County

Lake City, Florida, 32055, United States

Location

Suwannee County

Live Oak, Florida, 32064, United States

Location

Baker County

Macclenny, Florida, 32063, United States

Location

Madison County

Madison, Florida, 32340, United States

Location

Lafayette County

Mayo, Florida, 32066, United States

Location

Putnam County

Palatka, Florida, 32131, United States

Location

Taylor County

Perry, Florida, 32348, United States

Location

Bradford County

Starke, Florida, 32091, United States

Location

Gilchrist County

Trenton, Florida, 32693, United States

Location

Related Publications (2)

• Perri MG, Shankar MN, Daniels MJ, Durning PE, Ross KM, Limacher MC, Janicke DM, Martin AD, Dhara K, Bobroff LB, Radcliff TA, Befort CA. Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206764. doi: 10.1001/jamanetworkopen.2020.6764.

  PMID: 32539150 DERIVED

• Perri MG, Ariel-Donges AH, Shankar MN, Limacher MC, Daniels MJ, Janicke DM, Ross KM, Bobroff LB, Martin AD, Radcliff TA, Befort CA. Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling. Contemp Clin Trials. 2019 Jan;76:55-63. doi: 10.1016/j.cct.2018.11.006. Epub 2018 Nov 6.

  PMID: 30408606 DERIVED

Related Links

• Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counseling

MeSH Terms

Conditions

Obesity; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Study Officials

• Michael G Perri, Ph.D., ABPP

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)