Study of Novel Approaches for Prevention

Young adults, aged 20-35 years, experience the greatest rate of weight gain, averaging 1-2
lbs/yr. Over time, this weight gain is associated with a worsening in cardiovascular disease
risk factors and an increase in the prevalence of metabolic syndrome. Given the difficulties
in producing sustained weight loss later in life, preventing weight gain from occurring
during this critical period is key to curbing the obesity epidemic. The Study of Novel
Approaches for Prevention (SNAP) is a 2-center randomized trial designed to test whether
behavioral interventions based on self-regulation can prevent weight gain in young adults
(18-35 years; body mass index (BMI) 21-30 kg/m2). Approximately 600 participants will be
recruited over two years and randomly assigned to a control condition (N=200),
self-regulation with small changes (N=200) or self-regulation with large changes (N=200). The
Small Changes group will be taught to make small, consistent, changes in eating and exercise
behavior to prevent weight gain or reverse weight gain if it occurs whereas the Large Changes
group will emphasize periodic, larger changes in eating and exercise, with a goal of
producing weight loss and thereby providing a buffer against anticipated weight gain. The
primary aim of the trial is to test whether the magnitude of weight gain from baseline across
an average planned follow-up of three years differs across the three groups, with a priori
hypotheses that weight gain will be greater in the Control group than in either intervention
and greater in the Small Changes than Large Changes group. Secondary aims are to compare the
three groups on a) the proportion of participants in the three groups who gain less than 1
pound over the planned follow-up, b) the mean difference in weight gain from baseline to
24-month follow-up, c) the changes in behaviors and psychosocial measures (diet, physical
activity, dietary restraint, frequency of self-weighing,depression, and occurrence of
abnormal eating behaviors), and d) the changes in cardiovascular disease risk factors (blood
pressure, lipids, insulin sensitivity, and waist circumference). The trial will also examine
the association among changes in behaviors, weight, and cardiovascular disease risk factors
and examine variables that may moderate the effects of the intervention (including gender,
ethnicity, initial BMI, age) and potential mediators of the effects of the intervention
(including changes in diet, activity, and self-regulatory behaviors). SNAP is member of the
Early Adult Reduction in Weight Through Lifestyle Interventions (EARLY) consortium of
clinical trials funded by the National Heart, Lung, and Blood Institute.

Inclusion Criteria:

1. BMI of 21 - 30 kg/m2

Exclusion Criteria:

1. Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is
provided by their health care provider.

2. Heart disease, heart problems or report being prescribed drugs for blood pressure or a
major heart condition, unless permission is provided by their health care provider.

3. Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that
may cause hypoglycemia.

4. Health problems which may influence the ability to walk for physical activity (e.g.
lower limb amputation) or other reasons why a person should not do physical activity,
unless permission is provided from their health care provider.

5. Health problems that may be associated with unintentional weight change or affect the
safety of a weight loss program, including report of a heart attack or stroke, chest
pain during periods of activity or rest, loss of consciousness, active tuberculosis,
HIV, chronic hepatitis B or C, inflammatory bowel disease requiring treatment within
the past year, thyroid disease, renal disease, liver disease, hospitalization for
asthma in the past year, or cancer within the past 5 years (except for non-melanoma
skin cancers or early stage cervical cancer) or chronic use of steroid medication.

6. Report of a past diagnosis of or treatment for a Diagnostic and Statistical Manual of
Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia
nervosa or bulimia nervosa) or meet criteria for anorexia or bulimia nervosa during
screening for this trial

7. Report of a past diagnosis of or current symptoms of alcohol or substance dependence.

8. Currently pregnant, pregnant within the past 6 months, or planning to become pregnant
within the next 6 months.

9. History of schizophrenia, manic depression, or bipolar disorder.

10. Hospitalization for depression or other psychiatric disorder within the past 12
months.

11. Having lost and maintained a weight loss of 10 pounds or more within the past 6 months
or are currently participating in a weight loss program, trying to gain weight, using
steroids for muscle mass or weight gain, taking weight loss medication, or have had
surgery for weight loss.

12. Participation in another weight loss or physical activity study that would interfere
with this study.

13. Another member of the household (or roommate) is a participant or staff member on this
trial.

14. Reason to suspect that the participant would not adhere to the study intervention or
assessment schedule (i.e., can't come to group on a regular basis; will be away for
more than two weeks during initial intervention phase or planning to move from the
area within next year).

15. Not able to speak and understand English.

16. Residence or place of work further than 30 miles from the intervention site.

17. Perceived inability to attend the 2 year data collection visit.

18. Does not have Internet access on a regular basis.