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Study of Novel Approaches for Prevention (SNAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mark A. Espeland, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01183689
First received: August 13, 2010
Last updated: March 15, 2016
Last verified: March 2016
  Purpose

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).


Condition Intervention
Body Weight Changes
Behavioral: Self-regulation theory

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Novel Approaches for Prevention

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Weight Gain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Magnitude of weight gain across an average planned follow-up of three years among the three arms


Secondary Outcome Measures:
  • Weight gain less than 1 pound [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare proportion of participants in the three groups who gain less than 1 pound over the planned follow-up of an average of three years

  • Weight gain differences [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Mean differences in weight gain among intervention groups at 24 months post-randomization

  • Behavior [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare the three groups on changes in behavior (e.g. diet, physical activity, abnormal eating behaviors, use of healthy and unhealthy weight control practices) and psychosocial measures (restraint, depression) over the average follow-up of three years

  • Cardiovascular disease risk factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare changes in cardiovascular disease risk factors (including blood pressure, lipids, insulin sensitivity, and waist circumference) across the three groups and examine the association of changes in cardiovascular disease risk factors with weight change and behavior changes

  • Demographic and Psychological Variables [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Examine demographic and psychological variables that may moderate the effects of the interventions, including initial BMI, ethnicity, age, scores on the Eating Inventory, and treatment preference

  • Mediators of the effect of the intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Examine potential mediators of the effect of the interventions, including changes in diet, physical activity, restraint, and change in self-regulatory behaviors

  • Obesity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Compare incidence rates of obesity and the proportions of participants who meet this criteria for obesity over time among the three groups


Other Outcome Measures:
  • Weight Gain [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Magnitude of weight gain across an average planned follow-up of six years among the three arms

  • Overweight and Obese [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Proportion of participants who transition to the next category (overweight or obese)

  • Gaining Weight [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Proportion of participants who exceed their baseline weight

  • Behavior [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Compare the three groups on changes in behavior (e.g. diet, physical activity, frequency of self-weighing, use of weight control strategies)

  • Health Outcomes [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Compare the three groups in changes in health outcomes, including body composition, glucose metabolism and lipid levels from baseline to 6 years


Enrollment: 599
Study Start Date: August 2010
Estimated Study Completion Date: May 2019
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
"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: Self-regulation with small behavior changes
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).
Behavioral: 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: Self-regulation with large behavior changes
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).
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183689

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27559
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Wake Forest University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Rena Wing, PhD The Miriam Hospital
Principal Investigator: Judy Bahnson Wake Forest School of Medicine
Principal Investigator: Wei Lang, PhD Wake Forest School of Medicine
Principal Investigator: Mark A Espeland, PhD Wake Forest School of Medicine
Principal Investigator: Deborah Tate, PhD University of North Carolina, Chapel Hill
Principal Investigator: Beth Lewis, MD University of Alabama at Birmingham