ObesityRural LEAPNCT02054624
Rural Lifestyle Eating and Activity Program (Rural LEAP)
A study testing Lifestyle intervention, Individual and All Groups in people with Obesity, run by University of Florida at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle intervention, Individual and All Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 14 sitesUnited States
- Study dates
- Aug 2013to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21 to 75 years
- Body Mass Index: 30 to 45 kg/m**2
Who cannot join
- 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 (patients with diabetes 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Levy County
Bronson, Florida, 32621
Flagler County
Bunnell, Florida, 32110
Dixie County
Cross City, Florida, 32628
Hamilton County
Jasper, Florida, 32052
Union County
Lake Butler, Florida, 32054
Columbia County
Lake City, Florida, 32055
Suwannee County
Live Oak, Florida, 32064
Baker County
Macclenny, Florida, 32063
Madison County
Madison, Florida, 32340
Lafayette County
Mayo, Florida, 32066
Putnam County
Palatka, Florida, 32131
Taylor County
Perry, Florida, 32348
Bradford County
Starke, Florida, 32091
Gilchrist County
Trenton, Florida, 32693
About this study
Official title: Rural Lifestyle Eating and Activity Program
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.
Read the detailed description
If the participant agrees to participate, a number of tests will be performed to see if the participant is eligible to take part in the study. If so, these tests will be repeated after 4 months of treatment, and again after 22 months. Participants will be asked to complete a number of questionnaires. baseline, 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
Randomization
A member of the research team will contact participants by telephone or by mail if they eligible to take part in the study. Participants are randomly assigned to one of three groups. Random assignment is like rolling dice to decide which group a person is assigned to.
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 participants receive will depend on whether they are assigned to Group A, B, or C.
Phase 1 Treatment
During this time, participants 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.
- Participants will learn about nutrition, physical activity, and safe methods to lose weight. To help accomplish this goal, participants will be asked to keep a daily habit log on which participants will record everything they eat and drink each day. Participants 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 the participant takes each day. Participants will be asked to wear the pedometer each day, and write down on thier habit log each day the number of steps tracked by thier pedometer.
- Participants will be taught how to eat a healthy diet while taking in fewer calories than they are currently eating. This will usually mean reducing calorie intake by 500 to 1000 calories per day. Participants will participate in cooking demonstrations and will have a chance to sample healthy foods prepared during group meetings.
- Participants 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.
- Participants will be taught ways to increase their motivation to start and maintain changes in their 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 participants will be encouraged to maintain improved, healthy patterns of exercise and dietary intake, and to continue to monitor and record their 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 participants are assigned by the computer to Group A, they 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. These calls will be group phone calls; other participants will be on the call. 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 participants maintain lost weight.
Group B: This group will have follow-up contact by phone. If participants are assigned by the computer to Group B, they 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. These calls will be individual phone calls with the participant and a trained staff member that will include discussions of progress and will focus on strategies to help them maintain lost weight.
Group C: This group will have follow-up contact by mail. If participants are assigned by the computer to Group C, they 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.
If participants are in Group A or B four of their phone call treatment sessions will be audio recorded so that the researchers can determine if the treatment was delivered as planned.
- Conditions
- Obesity
- Being tested
- Lifestyle intervention, Health education control, Individual, All Groups
- Keywords
- Obesity, Rural Health, Exercise, Weight loss, Behavior change
- Medical subject headings
- Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
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.
Health education controlBehavioural
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.
IndividualBehavioural
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.
All GroupsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Health education control; Behavioral: All Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg) from month 4 to month 22
Weight is measured on a Tanita digital scale.
Measured: Change from month 4 to month 22
Secondary outcomes (2)
Percent of participants achieving 5% or greater weight losses at month 22
Weight is measured on a Tanita digital scale.
Measured: Baseline to month 22
Percent of participants achieving 10% or greater weight losses at month 22
Weight is measured on a Tanita digital scale.
Measured: Baseline to month 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2018
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael G Perri, Ph.D., ABPP, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054624
- Sponsor's protocol ID
- 29-2013-N
- Other IDs
- R18HL112720, IRB201600055
- Acronym
- Rural LEAP
- Status last verified
- Sep 2021
- First submitted
- 3 Feb 2014
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32539150Perri 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.
PubMed 30408606
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Lifestyle Eating and Activity Program
- ClinicalTrials.gov ID
- NCT02054624
- Acronym / sponsor ID
- Rural LEAP / 29-2013-N
- Conditions
- Obesity
- Keywords
- Obesity, Rural Health, Exercise, Weight loss, Behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If the participant agrees to participate, a number of tests will be performed to see if the participant is eligible to take part in the study. If so, these tests will be repeated after 4 months of treatment, and again after 22 months. Participants will be asked to complete a number of questionnaires. baseline, 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
Randomization
A member of the research team will contact participants by telephone or by mail if they eligible to take part in the study. Participants are randomly assigned to one of three groups. Random assignment is like rolling dice to decide which group a person is assigned to.
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 participants receive will depend on whether they are assigned to Group A, B, or C.
Phase 1 Treatment
During this time, participants 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.
- Participants will learn about nutrition, physical activity, and safe methods to lose weight. To help accomplish this goal, participants will be asked to keep a daily habit log on which participants will record everything they eat and drink each day. Participants 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 the participant takes each day. Participants will be asked to wear the pedometer each day, and write down on thier habit log each day the number of steps tracked by thier pedometer.
- Participants will be taught how to eat a healthy diet while taking in fewer calories than they are currently eating. This will usually mean reducing calorie intake by 500 to 1000 calories per day. Participants will participate in cooking demonstrations and will have a chance to sample healthy foods prepared during group meetings.
- Participants 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.
- Participants will be taught ways to increase their motivation to start and maintain changes in their 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 participants will be encouraged to maintain improved, healthy patterns of exercise and dietary intake, and to continue to monitor and record their 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 participants are assigned by the computer to Group A, they 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. These calls will be group phone calls; other participants will be on the call. 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 participants maintain lost weight.
Group B: This group will have follow-up contact by phone. If participants are assigned by the computer to Group B, they 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. These calls will be individual phone calls with the participant and a trained staff member that will include discussions of progress and will focus on strategies to help them maintain lost weight.
Group C: This group will have follow-up contact by mail. If participants are assigned by the computer to Group C, they 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.
If participants are in Group A or B four of their phone call treatment sessions will be audio recorded so that the researchers can determine if the treatment was delivered as planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual | Active comparator | Behavioral: Individual, Behavioral: All GroupsThe 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. |
| Lifestyle intervention | Active comparator | Behavioral: Lifestyle intervention, Behavioral: All GroupsThe 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. |
| Health Education Control | Active comparator | Behavioral: Health education control, Behavioral: All GroupsThe 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 21 to 75 years
- Body Mass Index: 30 to 45 kg/m**2
Key exclusion criteria (4 listed)
- 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 (patients with diabetes 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionThe 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. | Behavioural | Lifestyle intervention |
| Health education controlThe 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. | Behavioural | Health Education Control |
| IndividualThe 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. | Behavioural | Individual |
| All GroupsAll 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 | Behavioural | Health Education Control, Individual, Lifestyle intervention |
Primary outcome
Change in body weight (kg) from month 4 to month 22
Time frame: Change from month 4 to month 22
Weight is measured on a Tanita digital scale.
2 secondary outcomes
Percent of participants achieving 5% or greater weight losses at month 22
Time frame: Baseline to month 22
Percent of participants achieving 10% or greater weight losses at month 22
Time frame: Baseline to month 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 32539150Perri 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.
- Derived from this study: PubMed 30408606Perri 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.
- Design of the Rural LEAP randomized trial: An evaluation of extended-care programs for weight management delivered via group or individual telephone counselingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Perri, Ph.D., ABPP principal investigator
University of Florida
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention, Individual and All Groups in people with Obesity, run by University of Florida at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) from month 4 to month 22 (time frame: Change from month 4 to month 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02054624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.