Overview

This trial is active, not recruiting.

Condition body weight changes
Treatment self-regulation theory
Sponsor Wake Forest University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date August 2010
End date December 2014
Trial size 599 participants
Trial identifier NCT01183689, 5U01HL090875, 703

Summary

The Study of Novel Approaches for Prevention (SNAP) is 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). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the 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.

SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.
(Experimental)
Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).
self-regulation theory
Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.
(Experimental)
Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).
self-regulation theory
Participants randomized to either of these two groups will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate either large or small changes.

Primary Outcomes

Measure
Weight Gain
time frame: 3 years

Secondary Outcomes

Measure
Weight gain less than 1 pound
time frame: 3 years
Weight gain differences
time frame: 2 years
Behavior
time frame: 3 years
Cardiovascular disease risk factors
time frame: 3 years
Demographic and Psychological Variables
time frame: 3 years
Mediators of the effect of the intervention
time frame: 3 years
Obesity
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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.

Additional Information

Official title Study of Novel Approaches for Prevention
Principal investigator Judy Bahnson
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.