Overview

This trial was last updated 6 days ago.
Condition obesity
Treatments lifestyle intervention, health education control, individual, all groups
Sponsor University of Florida
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date August 2013
End date March 2018
Trial size 540 participants
Trial identifier NCT02054624, 29-2013, R18HL112720

Summary

The purpose of this research study is to learn about ways to help overweight adults 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 overweight and obese people 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.

You are being asked to be in this research study because increased weight and obesity are major health problems in the United States. You have been identified as being overweight or obese. People who are obese 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.

Recruiting in the following locations…

United States Florida
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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 you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months.
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 you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months.
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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).
(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 you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months.
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 you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months.
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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).
(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 you will receive you 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 you maintain lost weight.
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 you will receive you 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 you maintain lost weight.
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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).

Primary Outcomes

Measure
Change in body weight (kg) from baseline to month four
time frame: Change from baseline to month 4
Change in body weight (kg) from baseline to month 22
time frame: Change in baseline to month 22

Secondary Outcomes

Measure
Blood pressure (mmHg) from baseline to month 4
time frame: Change from baseline to month 4
LDL-Cholesterol (mg/dL) change in baseline to month 4
time frame: Change from baseline to month 4
HDL-Cholesterol (mg/dL) change in baseline to month 4
time frame: Change from baseline to month 4
Triglycerides (mg/dL) change from baseline to month 4
time frame: Change from baseline to month 4
Fasting blood glucose (mmol/L) change in baseline to month 4
time frame: Change from baseline to month 4
Glycated hemoglobin (hemoglobin A1c, HbA1c, A1c)
time frame: Change in glycated hemoglobin from baseline to month four
High-sensitivity C-reactive Protein (hsCRP)
time frame: Change in high-sensitivity C-reactive Protein from baseline to four months
400 meter walk test (m/s)
time frame: Change in pace from baseline to four months
Physical activity - Accelerometry (METS)
time frame: Change in physical activity output from baseline to month four
Physical activity - steps
time frame: Change in average daily step count from baseline to four months
Dietary intake (kcals)
time frame: Change in caloric intake from baseline to four months
Dietary intake - Dietary History Questionnaire
time frame: Change in caloric intake from baseline to four months
Waist circumference (cm)
time frame: Change in waist circumference from baseline to four months
Health Related Quality of Life
time frame: Change in Health Related Quality of Life measured by likert scale from baseline to month four
Cost Analysis
time frame: Cost effectiveness of the intervention from baseline to month four
Blood pressure (mmHg)
time frame: Change in systolic and diastolic blood pressure from baseline to 22 months
LDL-Cholesterol (mg/dL)
time frame: Change in blood LDL-Cholesterol concentration from baseline to 22 months
HDL-Cholesterol (mg/dL)
time frame: Change in blood HDL-Cholesterol concentration from baseline to 22 months
Triglycerides (mg/dL)
time frame: Change in blood triglyceride concentration from baseling to 22 months
Fasting blood glucose (mmol/L)
time frame: Change in fasting blood glucose concentration from baseline to 22 months
Glycated hemoglobin (hemoglobin A1c, HbA1c, A1c)
time frame: Change in glycated hemoglobin from baseline to month 22
High-sensitivity C-reactive Protein (hsCRP)
time frame: Change in high-sensitivity C-reactive Protein from baseline to 22 months
400 meter walk test (m/s)
time frame: Change in pace from baseline to 22 months
Physical activity - Accelerometry (METS)
time frame: Change in physical activity output from baseline to month 22
Physical activity - steps
time frame: Change in average daily step count from baseline to 22 months
Dietary intake (kcals)
time frame: Change in caloric intake from baseline to 22 months
Dietary intake - Dietary History Questionnaire
time frame: Change in caloric intake from baseline to 22 months
Waist circumference (cm)
time frame: Change in waist circumference from baseline to 22 months
Health Related Quality of Life
time frame: Change in Health Related Quality of Life measured by likert scale from baseline to month 22
Cost Analysis
time frame: Cost effectiveness of the intervention from baseline to month 22

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

Inclusion Criteria: - Age: 21 to 75 years - Body Mass Index: 30 to 45 kg/m**2 Exclusion Criteria: - 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. - Metabolic exclusions: fasting blood glucose > 125 mg/dl at screening if not known to be diabetic (diabetic patients under active treatment will be enrolled if approved by primary provider); fasting serum triglycerides > 400 mg/dl at screening; resting blood pressure > 150/100 mm Hg. - Medication exclusions: antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or Tuberculosis; chemotherapeutic drugs; or use of prescription weight-loss drugs within six months. - 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

Additional Information

Official title Rural Lifestyle Eating and Activity Program
Principal investigator Michael G Perri, Ph.D., ABPP
Description If you agree to participate, you will first have a number of tests performed on you to see if you are eligible to take part in the study. If you are eligible, these tests will be repeated after 4 months of treatment, and again after 22 months. You also will be asked to complete a number of questionnaires. If you are eligible, you will be asked to complete these questionnaires again after 4 months of treatment, and again after 10, 16, and 22 months. The different tests and measures are listed below. Questionnaires, Height, Weight, Waist Measurement, Blood Pressure, Heart Rate, Electrocardiogram, Blood Sample (2 tablespoons), Urine Sample, and a Urine Pregnancy test for females, 400 Meter Walking Test, Accelerometers (an armband device the size of a deck of cards that will record your physical activity and movement throughout each day). Randomization A member of the research team will contact you by telephone or by mail to tell you whether you are eligible to take part in the study. If you are eligible to participate, a computer will randomly assign you to one of three groups. Random assignment is like rolling dice to decide which group a person is assigned to. You will not get to choose which group you are assigned to, and the researchers will not get to choose which group you are assigned to. A computer will make your assignment. The three groups are described below: Group A: 4 months of weight loss treatment plus 12 months of follow-up contact by telephone. The follow-up telephone contacts in Group A will involve group discussion with a trained staff member and other participants. Group B: 4 months of weight loss treatment plus 12 months of follow-up contacts by telephone. The follow-up telephone contacts in Group B will involve individual, one-on-one discussion with a trained staff member. Group C: 4 months of weight loss treatment plus 12 months of follow-up contacts by mail and e-mail. Weight Loss Treatments The weight-loss treatments in this study will include two phases. Phase 1 will last 4 months. Phase 2 will last 12 more months. Everybody in Groups A, B, and C will have the same Phase 1 weight-loss treatment program for 4 months. However, the type of Phase 2 follow-up program that you receive will depend on whether you are assigned to Group A, B, or C. Phase 1 Treatment During this time, you will meet each week with a group leader and a group of about 10 other adults. The meetings will take place at the Cooperative Extension Office. The group leader will be a Family and Consumer Sciences Agent who has had special training in nutrition education or a staff member who has had special training in weight-management. The group meetings will last about 90 minutes per week. All group meeting will be audio recorded so that the researchers can determine if the treatment was delivered as planned. There are four major goals for the group sessions. 1. You will learn about nutrition, physical activity, and safe methods to lose weight. To help accomplish this goal, you will be asked to keep a daily habit log on which you will record everything you eat and drink each day. You will also be given a pedometer. A pedometer is a small device about the size of a pager that keeps track of how many steps you take each day. You will be asked to wear the pedometer each day, and write down on your habit log each day the number of steps tracked by your pedometer. 2. You will be taught how to eat a healthy diet while taking in fewer calories than you are currently eating. This will usually mean reducing your calorie intake by 500 to 1000 calories per day. You will participate in cooking demonstrations and will have a chance to sample healthy foods prepared during group meetings. 3. You will be taught how to set up a regular routine of increased physical activity or exercise. This will usually involve a walking program of 30 minutes per day. 4. You will be taught ways to increase your motivation to start and maintain changes in your eating and exercise habits. Phase 2 Treatments Phase 2 of the program will begin after the completion of Phase 1 and will last for 12 months. Phase 2 will involve follow-up programs to help group members continue their weight management efforts. During Phase 2 you will be encouraged to maintain improved, healthy patterns of exercise and dietary intake, and to continue to monitor and record your dietary intake and pedometer steps on a regular basis. The follow-up programs for all Groups will involve two contacts per month for the first 6 months and one contact per month for the next 6 months. However, the type of contact will be different for each Treatment Group. Group A: This group will have follow-up contact by phone. If you are assigned by the computer to Group A, you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months. These calls will be group phone calls; other participants will be on the call with you. These group phone calls will be led by a trained group leader and will include discussions of progress and will focus on strategies to help you maintain lost weight. Group B: This group will have follow-up contact by phone. If you are assigned by the computer to Group B, you will receive two phone calls per month from your group leader for the first 6 months, and one phone call per month for the next 6 months. These calls will be individual phone calls with you and a trained staff member that will include discussions of progress and will focus on strategies to help you maintain lost weight. Group C: This group will have follow-up contact by mail. If you are assigned by the computer to Group C, you 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 you maintain lost weight. If you are in Group A or B four of your phone call treatment sessions will be audio recorded so that the researchers can determine if the treatment was delivered as planned.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Florida.