Rural Lifestyle Eating and Activity Program (Rural LEAP)

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

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.

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 (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