Study of Novel Approaches for Prevention

NCT01183689 | Completed Results DMC

• 2 other identifiers: IRB000100975U01HL090875
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 2

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; 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).

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

• Weight Changes From Baseline Over Follow-up.

  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.

  3 years

Secondary Outcomes (20)

• Weight Gain 1 Pound or More at Any Time Over Follow-up

  3 years

• Mean Weight Changes

  2 years

• Mean Changes in Systolic Blood Pressure

  Measured at 2 Years

• Mean Changes From Baseline in Diastolic Blood Pressure

  2 years

• Mean Changes From Baseline to 2 Years in Total Cholesterol

  2 years

Other Outcomes (1)

• 6 Year Weight Changes

  6 years

Study Arms (3)

Control Group

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.

Small behavior 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 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: Small Behavior Changes

Large behavior 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).

Behavioral: Large Behavior Changes

Interventions

Small Behavior Changes BEHAVIORAL

The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain. Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time. Exercise: At the start of the program, participants will be given a pedometer and asked to record their current or baseline number of steps. They will then be given the goal of increasing their daily steps by 2000 steps per day over this baseline level.

Also known as: Small Behavior Changes plus self-regulation

Small behavior changes

Large Behavior Changes BEHAVIORAL

The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood. Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds. Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes per day) using activities similar in intensity to brisk walking.

Also known as: Large Behavior Changes plus self-regulation

Large behavior changes

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Wake Forest University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27559, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (14)

• Hayes JF, LaRose JG, Gorin AA, Lewis CE, Bahnson J, Phelan S, Wing RR; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Weight gain prevention interventions in the Study of Novel Approaches to Weight Gain Prevention (SNAP) trial promote ideal cardiovascular health in young adults. Obesity (Silver Spring). 2023 Jun;31(6):1530-1537. doi: 10.1002/oby.23753. Epub 2023 May 8.

  PMID: 37157110 DERIVED

• Corso LML, Wing RR, Tate DF, Espeland MA, Blanchard BE, McCaffery JM. Uric acid as a predictor of weight gain and cardiometabolic health in the Study of Novel Approaches to Weight Gain Prevention (SNAP) study. Int J Obes (Lond). 2022 Aug;46(8):1556-1559. doi: 10.1038/s41366-022-01131-1. Epub 2022 May 2.

  PMID: 35501471 DERIVED

• Wing RR, Espeland MA, Tate DF, Perdue LH, Bahnson J, Polzien K, Robichaud EF, LaRose JG, Gorin AA, Lewis CE, Jelalian E; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Weight Gain Over 6 Years in Young Adults: The Study of Novel Approaches to Weight Gain Prevention Randomized Trial. Obesity (Silver Spring). 2020 Jan;28(1):80-88. doi: 10.1002/oby.22661.

  PMID: 31858732 DERIVED

• LaRose JG, Neiberg RH, Evans EW, Tate DF, Espeland MA, Gorin AA, Perdue L, Hatley K, Lewis CE, Robichaud E, Wing RR; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Dietary outcomes within the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Jan 31;16(1):14. doi: 10.1186/s12966-019-0771-z.

  PMID: 30704533 DERIVED

• Olson KL, Neiberg RH, Tate DF, Garcia KR, Gorin AA, Lewis CE, Unick J, Wing RR. Weight and Shape Concern Impacts Weight Gain Prevention in the SNAP Trial: Implications for Tailoring Intervention Delivery. Obesity (Silver Spring). 2018 Aug;26(8):1270-1276. doi: 10.1002/oby.22212. Epub 2018 Jun 28.

  PMID: 29956495 DERIVED

• McCaffery JM, Ordovas JM, Huggins GS, Lai CQ, Espeland MA, Tate DF, Wing RR. Weight gain prevention buffers the impact of CETP rs3764261 on high density lipoprotein cholesterol in young adulthood: The Study of Novel Approaches to Weight Gain Prevention (SNAP). Nutr Metab Cardiovasc Dis. 2018 Aug;28(8):816-821. doi: 10.1016/j.numecd.2018.02.018. Epub 2018 Mar 6.

  PMID: 29699816 DERIVED

• Unick JL, Lang W, Williams SE, Bond DS, Egan CM, Espeland MA, Wing RR, Tate DF; SNAP Research Group. Objectively-assessed physical activity and weight change in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2017 Dec 4;14(1):165. doi: 10.1186/s12966-017-0620-x.

  PMID: 29202850 DERIVED

• Wing RR, Tate DF, Garcia KR, Bahnson J, Lewis CE, Espeland MA; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Improvements in Cardiovascular Risk Factors in Young Adults in a Randomized Trial of Approaches to Weight Gain Prevention. Obesity (Silver Spring). 2017 Oct;25(10):1660-1666. doi: 10.1002/oby.21917. Epub 2017 Aug 7.

  PMID: 28782918 DERIVED

• Unick JL, Lang W, Tate DF, Bond DS, Espeland MA, Wing RR. Objective Estimates of Physical Activity and Sedentary Time among Young Adults. J Obes. 2017;2017:9257564. doi: 10.1155/2017/9257564. Epub 2017 Jan 2.

  PMID: 28116151 DERIVED

• Crane MM, LaRose JG, Espeland MA, Wing RR, Tate DF. Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies. Trials. 2016 Jun 8;17(1):282. doi: 10.1186/s13063-016-1411-4.

  PMID: 27278474 DERIVED

• Wing RR, Tate DF, Espeland MA, Lewis CE, LaRose JG, Gorin AA, Bahnson J, Perdue LH, Hatley KE, Ferguson E, Garcia KR, Lang W; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Innovative Self-Regulation Strategies to Reduce Weight Gain in Young Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized Clinical Trial. JAMA Intern Med. 2016 Jun 1;176(6):755-62. doi: 10.1001/jamainternmed.2016.1236.

  PMID: 27136493 DERIVED

• Wing RR, Tate D, LaRose JG, Gorin AA, Erickson K, Robichaud EF, Perdue L, Bahnson J, Espeland MA. Frequent self-weighing as part of a constellation of healthy weight control practices in young adults. Obesity (Silver Spring). 2015 May;23(5):943-9. doi: 10.1002/oby.21064. Epub 2015 Apr 10.

  PMID: 25865175 DERIVED

• Tate DF, LaRose JG, Griffin LP, Erickson KE, Robichaud EF, Perdue L, Espeland MA, Wing RR. Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost. Trials. 2014 Aug 16;15:326. doi: 10.1186/1745-6215-15-326.

  PMID: 25128185 DERIVED

• Wing RR, Tate D, Espeland M, Gorin A, LaRose JG, Robichaud EF, Erickson K, Perdue L, Bahnson J, Lewis CE. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. BMC Public Health. 2013 Apr 4;13:300. doi: 10.1186/1471-2458-13-300.

  PMID: 23556505 DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mark Espeland
• Organization: Wake Forest University School of Medicine

mespelan@wakehealth.edu

336-716-2826

Study Officials

• Rena Wing, PhD

  The Miriam Hospital

  STUDY CHAIR

• Judy Bahnson

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Wei Lang, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Mark A Espeland, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Deborah Tate, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Beth Lewis, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: December 31, 2014
• Study Completion: September 30, 2018
• Last Updated: January 14, 2020
• Results First Posted: May 7, 2018

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)