Rural Lifestyle Eating and Activity Program (Rural LEAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02054624
First received: February 3, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Lifestyle intervention
Behavioral: Health education control
Behavioral: Individual
Behavioral: All Groups

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rural Lifestyle Eating and Activity Program

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in body weight (kg) from baseline to month four [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    Weight is measured on a Tanita digital scale.

  • Change in body weight (kg) from baseline to month 22 [ Time Frame: Change in baseline to month 22 ] [ Designated as safety issue: No ]
    Weight is measured on a Tanita digital scale.


Secondary Outcome Measures:
  • Blood pressure (mmHg) from baseline to month 4 [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    A clinical staff member will take the blood pressure from the right arm and also count the heart rate for 30 seconds. Blood pressure and heart rate will be measured 1 or 2 more times. The change in systolic and diastolic blood pressure from baseline to four months will be reported.

  • LDL-Cholesterol (mg/dL) change in baseline to month 4 [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of LDL-Cholesterol concentration in blood.

  • HDL-Cholesterol (mg/dL) change in baseline to month 4 [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of HDL-Cholesterol concentration in blood.

  • Triglycerides (mg/dL) change from baseline to month 4 [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of triglyceride concentration in blood.

  • Fasting blood glucose (mmol/L) change in baseline to month 4 [ Time Frame: Change from baseline to month 4 ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of fasting blood glucose in blood.

  • Glycated hemoglobin (hemoglobin A1c, HbA1c, A1c) [ Time Frame: Change in glycated hemoglobin from baseline to month four ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of sugar the blood.

  • High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: Change in high-sensitivity C-reactive Protein from baseline to four months ] [ Designated as safety issue: No ]
    A staff member will take about 2 tablespoons of blood from the arm. The blood will be studied to find out the levels of sugar the blood.

  • 400 meter walk test (m/s) [ Time Frame: Change in pace from baseline to four months ] [ Designated as safety issue: No ]
    A trained staff member will supervise participants in the completion of a 400 Meter walking test. They will be instructed to walk 400 meters at a standard pace on a clearly marked indoor course. Time it takes to complete the walk will be recorded. Participants will be allowed to stop and rest or stop and not complete the test at anytime.

  • Physical activity - Accelerometery (METS) [ Time Frame: Change in physical activity output from baseline to month four ] [ Designated as safety issue: No ]
    An accelerometer will be worn on the arm for seven days, recording physical activity and movement throughout each day.

  • Physical activity - steps [ Time Frame: Change in average daily step count from baseline to four months ] [ Designated as safety issue: No ]
    A pedometer will be worn on the waist to record the number of steps taken each day.

  • Dietary intake (kcals) [ Time Frame: Change in caloric intake from baseline to four months ] [ Designated as safety issue: No ]
    Daily habit logs will be kept including details on all foods and beverage eaten each day. Specifically, name of food/beverage, amount and calorie content will be recorded.

  • Dietary intake - Dietary History Questionnaire [ Time Frame: Change in caloric intake from baseline to four months ] [ Designated as safety issue: No ]
    This questionnaire asks questions about your overall dietary intake over the last year and is completed by computer on the National Institutes of Health Dietary History Questionnaire website.

  • Waist circumference (cm) [ Time Frame: Change in waist circumference from baseline to four months ] [ Designated as safety issue: No ]
    A staff member will use a tape measure to measure your waist.

  • Health Related Quality of Life [ Time Frame: Change in Health Related Quality of Life measured by likert scale from baseline to month four ] [ Designated as safety issue: No ]
    These questionnaires ask about health, eating and exercise habits, and thoughts and feelings. This information will be used to help determine how personal factors (e.g., age, gender, race, education, income, marital status) are associated with change in weight.

  • Cost Analysis [ Time Frame: Cost effectiveness of the intervention from baseline to month four ] [ Designated as safety issue: Yes ]
    Questionnaires asking about background information will be completed to assess the economic impact of this program.

  • Blood pressure (mmHg) [ Time Frame: Change in systolic and diastolic blood pressure from baseline to 22 months ] [ Designated as safety issue: No ]
    You will sit quietly for 5 minutes without talking or distractions. The clinical staff member will then take your blood pressure from your right arm. The staff member will also count your heart rate for 30 seconds. Your blood pressure and heart rate will be measured 1 or 2 more times.

  • LDL-Cholesterol (mg/dL) [ Time Frame: Change in blood LDL-Cholesterol concentration from baseline to 22 months ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of fats (lipids) in your blood.

  • HDL-Cholesterol (mg/dL) [ Time Frame: Change in blood HDL-Cholesterol concentration from baseline to 22 months ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of fats (lipids) in your blood.

  • Triglycerides (mg/dL) [ Time Frame: Change in blood triglyceride concentration from baseling to 22 months ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of fats (lipids) in your blood.

  • Fasting blood glucose (mmol/L) [ Time Frame: Change in fasting blood glucose concentration from baseline to 22 months ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of sugar in your blood.

  • Glycated hemoglobin (hemoglobin A1c, HbA1c, A1c) [ Time Frame: Change in glycated hemoglobin from baseline to month 22 ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of sugar in your blood.

  • High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: Change in high-sensitivity C-reactive Protein from baseline to 22 months ] [ Designated as safety issue: No ]
    The staff member will take about 2 tablespoons of blood from your arm. The blood will be studied to find out the levels of sugar in your blood.

  • 400 meter walk test (m/s) [ Time Frame: Change in pace from baseline to 22 months ] [ Designated as safety issue: No ]
    A trained staff member will supervise you in the completion of a 400 Meter walking test. You will be instructed to walk 400 meters at your own pace, and the time it takes you to complete the walk will be recorded. You will walk on a clearly marked indoor course. You will be allowed to stop and rest or stop and not complete the test at anytime. If you experience any abnormal symptoms during the test, such as chest pain or severe shortness of breath, you should immediately inform the test supervisor. If you experience any symptoms during the walk, such as shortness of breath, feelings of dizziness, or excessive tiredness (fatigue), you will be asked to remain in the testing area for 15 minutes of observation following the test.

  • Physical activity - Accelerometery (METS) [ Time Frame: Change in physical activity output from baseline to month 22 ] [ Designated as safety issue: No ]
    You will be asked to wear an accelerometer for seven days. The accelerometer is an armband device the size of a deck of cards that will record your physical activity and movement throughout each day.

  • Physical activity - steps [ Time Frame: Change in average daily step count from baseline to 22 months ] [ Designated as safety issue: No ]
    You will be given a pedometer (at no cost to you). 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.

  • Dietary intake (kcals) [ Time Frame: Change in caloric intake from baseline to 22 months ] [ Designated as safety issue: No ]
    Participants will be asked to keep a daily habit log on which you will record everything you eat and drink each day. Specifically, name of food/beverage, amount and calorie content will be recorded.

  • Dietary intake - Dietary History Questionnaire [ Time Frame: Change in caloric intake from baseline to 22 months ] [ Designated as safety issue: No ]
    This questionnaire asks questions about your overall dietary intake over the last year and is completed by computer on the National Institutes of Health Dietary History Questionnaire website.

  • Waist circumference (cm) [ Time Frame: Change in waist circumference from baseline to 22 months ] [ Designated as safety issue: No ]
    A staff member will use a tape measure to measure your waist.

  • Health Related Quality of Life [ Time Frame: Change in Health Related Quality of Life measured by likert scale from baseline to month 22 ] [ Designated as safety issue: No ]
    You will be asked to fill out some questionnaires that ask you about yourself, including your health, your eating and exercise habits, and your thoughts and feelings. This information will be used to help us understand how personal factors (e.g., age, gender, race, education, income, marital status) are associated with change in weight.

  • Cost Analysis [ Time Frame: Cost effectiveness of the intervention from baseline to month 22 ] [ Designated as safety issue: Yes ]
    You will be asked to complete a background information questionnaire; this information will be used to assess the economic impact of this program,


Estimated Enrollment: 540
Study Start Date: August 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 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.

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 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.

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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).
Active Comparator: 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 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.

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 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.

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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).
Active Comparator: 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.

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 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.

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, accelerometer (an armband device the size of a deck of cards to record physical activity and movement each day).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02054624

Contacts
Contact: Michael G Perri, Ph.D. 352-273-6214 mperri@phhp.ufl.edu

Locations
United States, Florida
Levy County Recruiting
Bradford, Florida, United States, 32621
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Dixie County Not yet recruiting
Cross City, Florida, United States, 32628
Principal Investigator: Michael G Perri, PhD ABPP         
Union County Not yet recruiting
Lake Butler, Florida, United States, 32054
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Columbia County Recruiting
Lake City, Florida, United States, 32055
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Suwannee County Recruiting
Live Oak, Florida, United States, 32064
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Putnam County Recruiting
Palatka, Florida, United States, 32131
Contact: Kristina von Castel-Roebrts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Taylor County Recruiting
Perry, Florida, United States, 32348
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Bradford County Not yet recruiting
Starke, Florida, United States, 32091
Principal Investigator: Michael G Perri, PhD ABPP         
Gilchrist County Not yet recruiting
Trenton, Florida, United States, 32693
Contact: Kristina von Castel-Roberts, PhD RD    352-273-5235    ufweightstudy@phhp.ufl.edu   
Principal Investigator: Michael G Perri, PhD ABPP         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael G Perri, Ph.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02054624     History of Changes
Other Study ID Numbers: 29-2013, R18HL112720
Study First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Obesity
Rural Health
Exercise
Weight loss
Behavior change

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014