Trial Outcomes & Findings for Study of Novel Approaches for Prevention (NCT NCT01183689)

SNAP targeted an enrollment of 600 participants, aged 18-35 years, with a BMI of 21.0 to 30.9. Participants were recruited from 2 clinical sites (Providence, RI and Chapel Hill, NC). The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period (Aug 2010-Feb 2012).

Participants were pre-screened online and by telephone before attending an orientation, followed by two screening visits. 609 participants were randomized; although 10 participants never attended the randomization visit and did not learn of their group assignment.

Study of Novel Approaches for Prevention

Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.

Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.

Mean differences in weight changes among intervention groups at 24 months post-randomization

Compare changes in systolic blood pressure across the three intervention groups

Change from baseline to 2 years in diastolic blood pressure

Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)

Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.

The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint). Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition). REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, \& Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control. REF: Westenhoefer, J., Stunkard, A. J., \& Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64.

Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, \& Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control. REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes. Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention

Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance

Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)

Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures

Mean change in fasting insulin (uU/ml) from baseline to 2 years

Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., \& Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.

We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) \* fasting insulin in (uU/mL).

Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy. REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335.

Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.

Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week

Changes from baseline to year 6 in body weight