Clinical trial NCT01183689: Study of Novel Approaches for Prevention
Official title: Study of Novel Approaches for Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-18
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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 an increase in the prevalence of metabolic syndrome. Given the difficulties in producing sustained weight loss later in life, preventing weight gain from occurring during this critical period is key to curbing the obesity epidemic. The Study of Novel Approaches for Prevention (SNAP) is a 2-center 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). Approximately 600 participants will be recruited over two years and randomly assigned to a control condition (N=200), self-regulation with small changes (N=200) or self-regulation with large changes (N=200). The Small Changes group will be taught to make small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs whereas the Large Changes group will emphasize periodic, larger changes in eating and exercise, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gain. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average planned follow-up of three years differs across the three groups, with a priori 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. Secondary aims are to compare the three groups on a) the proportion of participants in the three groups who gain less than 1 pound over the planned follow-up, b) the mean difference in weight gain from baseline to 24-month follow-up, c) the changes in behaviors and psychosocial measures (diet, physical activity, dietary restraint, frequency of self-weighing,depression, and occurrence of abnormal eating behaviors), and d) the changes in cardiovascular disease risk factors (blood pressure, lipids, insulin sensitivity, and waist circumference). The trial will also examine the association among changes in behaviors, weight, and cardiovascular disease risk factors and examine variables that may moderate the effects of the intervention (including gender, ethnicity, initial BMI, age) and potential mediators of the effects of the intervention (including changes in diet, activity, and self-regulatory behaviors). SNAP is member of the Early Adult Reduction in Weight Through Lifestyle Interventions (EARLY) consortium of clinical trials funded by the National Heart, Lung, and Blood Institute.

Eligibility 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.

Primary outcomes:
measure: Weight Changes From Baseline Over Follow-up.
timeFrame: 3 years
Secondary outcomes:
measure: Weight Gain 1 Pound or More at Any Time Over Follow-up
timeFrame: 3 years
measure: Mean Weight Changes
timeFrame: 2 years
measure: Mean Changes in Systolic Blood Pressure
timeFrame: Measured at 2 Years
measure: Mean Changes From Baseline in Diastolic Blood Pressure
timeFrame: 2 years
measure: Mean Changes From Baseline to 2 Years in Total Cholesterol
timeFrame: 2 years
measure: Obesity
timeFrame: 3 years
measure: Dietary Restraint: Mean Change From Baseline to 2 Years
timeFrame: 2 years
measure: Disinhibition
timeFrame: Changes at 2 years
measure: Flexible Dietary Control
timeFrame: Changes from baseline to 2 years
measure: Rigid Dietary Control
timeFrame: Changes from baseline to 2 years
measure: General Health Index
timeFrame: Changes from baseline to 2 years
measure: Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: 2 years
measure: Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 2 years
measure: Mean Change in Fasting Glucose From Baseline to 2 Years
timeFrame: 2 years
measure: Mean Change in Fasting Insulin From Baseline to 2 Years
timeFrame: 2 years
measure: Depression Symptomatology
timeFrame: 2 years
measure: Insulin Resistance
timeFrame: Change from baseline to 2 years
measure: Total Energy Dietary Intake Per Day (Kcals)
timeFrame: Changes from baseline to 2 years in kilocalories
measure: Change in Waist Circumference (cm)
timeFrame: Change from baseline to 2 years
measure: Self-weighing
timeFrame: 2 years
Other outcomes:
measure: 6 Year Weight Changes
timeFrame: 6 years
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena Wing, PhD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Judy Bahnson
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Wei Lang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Mark A Espeland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Deborah Tate, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Beth Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.