Rural Lifestyle Eating and Activity Program (Rural LEAP)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

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.

        1. 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.

        2. 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.

        3. 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.

        4. 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.
    

Intervention name(s): Lifestyle intervention; Health education control; Individual; All Groups
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Rural Health; Exercise; Weight loss; Behavior change