Study of Novel Approaches for Prevention

Completed · Not applicable

Conditions studied: Weight Gain

In brief

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).

Key facts

Study ID

NCT01183689

Run by

Wake Forest University

People needed

599

Starts

2010-08-01

Expected to finish

2018-09-30

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI of 21 - 30 kg/m2

You may not qualify if…

• Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider.
• 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.
• Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that may cause hypoglycemia.
• 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.
• 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.
• 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
• Report of a past diagnosis of or current symptoms of alcohol or substance dependence.
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
• History of schizophrenia, manic depression, or bipolar disorder.
• Hospitalization for depression or other psychiatric disorder within the past 12 months.
• 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.
• Participation in another weight loss or physical activity study that would interfere with this study.
• Another member of the household (or roommate) is a participant or staff member on this trial.
• 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).
• Not able to speak and understand English.
• Residence or place of work further than 30 miles from the intervention site.
• Perceived inability to attend the 2 year data collection visit.
• Does not have Internet access on a regular basis.

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.