Status:
COMPLETED
Study of Novel Approaches for Prevention
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Weight Gain
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief 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;...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 1\. BMI of 21 - 30 kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT01183689
Start Date
August 1 2010
End Date
September 30 2018
Last Update
January 14 2020
Active Locations (2)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27559
2
The Miriam Hospital
Providence, Rhode Island, United States, 02903