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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL090875 | U.S. NIH Grant/Contract | View source |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain 1 Pound or More at Any Time Over Follow-up | Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Year Weight Changes | Changes from baseline to year 6 in body weight | 6 years |
Inclusion Criteria:
1. BMI of 21 - 30 kg/m2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27559 | United States | ||
| The Miriam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37157110 | Derived | 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. | |
| 35501471 | 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. |
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De-identified data can be obtained by request, conditional on a data use agreement.
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Participants were pre-screened online and by telephone before attending an orientation, followed by two screening visits. 609 participants were randomized; although 10 participants never attended the randomization visit and did not learn of their group assignment.
SNAP targeted an enrollment of 600 participants, aged 18-35 years, with a BMI of 21.0 to 30.9. Participants were recruited from 2 clinical sites (Providence, RI and Chapel Hill, NC). The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period (Aug 2010-Feb 2012).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). 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. |
| FG002 | 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). 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | kilograms | 3 years |
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Adverse Event Data were collected on all participants from the time the participant signed the consent throughout the duration of the study (an average follow-up of 3 years). Participants were asked at each visit (scheduled to occur at months 4, 12, 24, 36, and 48 depending on when participants were enrolled relative to the end of follow-up) to report any medical events that occurred. Participants were also allowed to contact the clinic staff to report an adverse events at any intervening time
Participants were asked about hospitalizations and any medical events at each study visit (4 months, 1 year, annually thereafter). Participants could also contact the study staff between visits to report an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Espeland | Wake Forest University School of Medicine | 336-716-2826 | mespelan@wakehealth.edu |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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| 3 years |
| Mean Weight Changes | Mean differences in weight changes among intervention groups at 24 months post-randomization | 2 years |
| Mean Changes in Systolic Blood Pressure | Compare changes in systolic blood pressure across the three intervention groups | Measured at 2 Years |
| Mean Changes From Baseline in Diastolic Blood Pressure | Change from baseline to 2 years in diastolic blood pressure | 2 years |
| Mean Changes From Baseline to 2 Years in Total Cholesterol | Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl) | 2 years |
| Obesity | Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations. | 3 years |
| Dietary Restraint: Mean Change From Baseline to 2 Years | The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint). Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | 2 years |
| Disinhibition | The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition). REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | Changes at 2 years |
| Flexible Dietary Control | Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control. REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64. | Changes from baseline to 2 years |
| Rigid Dietary Control | Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control. REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | Changes from baseline to 2 years |
| General Health Index | The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes. Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention | Changes from baseline to 2 years |
| Mean Changes in High Density Lipoprotein Cholesterol (HDL-C) | Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance | 2 years |
| Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C) | Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl) | 2 years |
| Mean Change in Fasting Glucose From Baseline to 2 Years | Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures | 2 years |
| Mean Change in Fasting Insulin From Baseline to 2 Years | Mean change in fasting insulin (uU/ml) from baseline to 2 years | 2 years |
| Depression Symptomatology | Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology. | 2 years |
| Insulin Resistance | We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL). | Change from baseline to 2 years |
| Total Energy Dietary Intake Per Day (Kcals) | Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy. REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335. | Changes from baseline to 2 years in kilocalories |
| Change in Waist Circumference (cm) | Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2. | Change from baseline to 2 years |
| Self-weighing | Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week | 2 years |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| 31858732 | 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. |
| 30704533 | 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. |
| 29956495 | 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. |
| 29699816 | 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. |
| 29202850 | 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. |
| 28782918 | 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. |
| 28116151 | 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. |
| 27278474 | 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. |
| 27136493 | 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. |
| 25865175 | 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. |
| 25128185 | 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. |
| 23556505 | 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. |
| BG001 | 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). 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. |
| BG002 | 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). 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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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). 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. |
| OG002 | 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). 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. |
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| Secondary | Weight Gain 1 Pound or More at Any Time Over Follow-up | Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. | Posted | Mean | Standard Error | percentage gaining 1 pound or more among | 3 years |
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| Secondary | Mean Weight Changes | Mean differences in weight changes among intervention groups at 24 months post-randomization | Posted | Mean | Standard Error | kilograms | 2 years |
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| Secondary | Mean Changes in Systolic Blood Pressure | Compare changes in systolic blood pressure across the three intervention groups | All participants with measurements at Year 2 | Posted | Mean | Standard Error | mmHg | Measured at 2 Years |
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| Secondary | Mean Changes From Baseline in Diastolic Blood Pressure | Change from baseline to 2 years in diastolic blood pressure | All participants providing data at 2 years | Posted | Mean | Standard Error | mmHg | 2 years |
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| Secondary | Mean Changes From Baseline to 2 Years in Total Cholesterol | Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl) | All participants with Year 2 measures | Posted | Mean | Standard Error | mg/dl | 2 years |
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| Secondary | Obesity | Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations. | Posted | Mean | Standard Error | percentage of participants | 3 years |
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| Secondary | Dietary Restraint: Mean Change From Baseline to 2 Years | The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint). Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | Posted | Mean | Standard Error | Units on a scale | 2 years |
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| Secondary | Disinhibition | The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition). REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | Posted | Mean | Standard Error | Units on a scale | Changes at 2 years |
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| Secondary | Flexible Dietary Control | Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control. REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64. | Posted | Mean | Standard Error | units on a scale | Changes from baseline to 2 years |
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| Secondary | Rigid Dietary Control | Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control. REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation. | Posted | Mean | Standard Error | 2 year changes in units on a scale | Changes from baseline to 2 years |
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| Secondary | General Health Index | The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes. Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention | Posted | Mean | Standard Error | 2 year changes in units on a scale | Changes from baseline to 2 years |
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| Secondary | Mean Changes in High Density Lipoprotein Cholesterol (HDL-C) | Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance | Mean changes among all participants with measurements at Year 2 | Posted | Mean | Standard Error | Mean Change from Baseline in mg/dl | 2 years |
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| Secondary | Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C) | Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl) | Mean changes from baseline among all participants with year 2 measures | Posted | Mean | Standard Error | Mean change in LDL-C in mg/dl | 2 years |
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| Secondary | Mean Change in Fasting Glucose From Baseline to 2 Years | Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures | All participants with measurements at 2 years | Posted | Mean | Standard Error | Mean change from baseline in mg/dl | 2 years |
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| Secondary | Mean Change in Fasting Insulin From Baseline to 2 Years | Mean change in fasting insulin (uU/ml) from baseline to 2 years | Posted | Mean | Standard Error | Mean changes at 2 years in uU/ml | 2 years |
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| Secondary | Depression Symptomatology | Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology. | All Participants with 2 year data | Posted | Mean | Standard Error | units on a scale | 2 years |
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| Secondary | Insulin Resistance | We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL). | Posted | Mean | Standard Error | HOMA-IR | Change from baseline to 2 years |
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| Secondary | Total Energy Dietary Intake Per Day (Kcals) | Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy. REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335. | Posted | Mean | Standard Error | kilocalories | Changes from baseline to 2 years in kilocalories |
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| Secondary | Change in Waist Circumference (cm) | Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2. | Posted | Mean | Standard Error | centimeters | Change from baseline to 2 years |
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| Secondary | Self-weighing | Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week | Posted | Count of Participants | Participants | 2 years |
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| Other Pre-specified | 6 Year Weight Changes | Changes from baseline to year 6 in body weight | Not Posted | 6 years | Participants |
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| 202 |
| 119 |
| 202 |
| EG001 | 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). 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. | 11 | 200 | 118 | 200 |
| EG002 | 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). 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. | 9 | 197 | 109 | 197 |
| Gall bladder | Gastrointestinal disorders | Non-systematic Assessment | Stomach pain related to gallstones |
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| Psychiatric | Psychiatric disorders | Non-systematic Assessment | One participant was hospitalized 3 times for depression. One participant was hospitalized twice for paranoid schizophrenia. One other participant was hospitalized once for depression. |
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| Obstetric | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Motor Vehicle Accident | General disorders | Non-systematic Assessment |
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| Tonsillectomy | Infections and infestations | Non-systematic Assessment | Tonsillectomy |
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| E-coli bacterial infection | Infections and infestations | Non-systematic Assessment | Hospitalization for E-coli bacterial infection |
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| Elective breast surgery | General disorders | Non-systematic Assessment | Elective breast surgery |
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| Stomach virus | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization for stomach virus |
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| Benign mass | General disorders | Non-systematic Assessment | Outpatient surgery for benign mass on left maxillary sinus |
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| Syncope | General disorders | Non-systematic Assessment | Syncope led to fall and hospitalization for concussion |
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| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization for Crohn's disease |
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| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Rheumatoid arthritis - increased pain following pregnancy -- condition was present 10 years prior to study entry |
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| Muscoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diabetes | Endocrine disorders | Systematic Assessment |
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| Gall bladder | Gastrointestinal disorders | Systematic Assessment |
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| Psychiatric | Psychiatric disorders | Systematic Assessment |
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| Ashthma Attack | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Obstetric | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Weight loss related | Metabolism and nutrition disorders | Systematic Assessment |
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| Motor vehicle accident | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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Not provided
| This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3, | generalized estimating equations | <0.05 | Odds Ratio (OR) | 2.28 | 2-Sided | 95 | 1.64 | 3.19 | Superiority |
| A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3. | Mixed Models Analysis | A linear contrast was used to compare groups 1 and 3 at 24 months. | <0.05 | Median Difference (Net) | 2.04 | 2-Sided | 95 | 1.11 | 2.98 | Superiority |
Mean differences in systolic blood pressure between groups 1 and 3 over time. |
| ANOVA |
| 0.13 |
| Mean Difference (Net) |
| 0.93 |
| 2-Sided |
| 95 |
| -0.98 |
| 2.84 |
| Superiority |
Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure. |
| ANOVA |
| 0.06 |
This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups. |
| Mean Difference (Net) |
| 0.92 |
| 2-Sided |
| 95 |
| -0.49 |
| 2.33 |
| Superiority |
Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.
| ANOVA |
| 0.73 |
This p-value is from a 2 degree of freedom test for differences among the 3 groups. |
| Mean Difference (Net) |
| -1.89 |
| 2-Sided |
| 95 |
| -4.36 |
| 0.58 |
| Superiority |
| Generalized estimating equations were used. Differences were summarized with odds ratios. | generalized estimating equations | 0.008 | This p-value is from a 2 degree of freedom test for differences among the 3 groups. | Odds Ratio (OR) | 2.13 | 2-Sided | 95 | 1.12 | 4.10 | Superiority |
| Differences among the 3 groups were based on analyses of variance. | ANOVA | 0.002 | This p-value is from a 2 degree of freedom test for differences among all 3 groups | Mean Difference (Net) | 0.55 | 2-Sided | 95 | 0.02 | 1.08 | Superiority |
| Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups. | ANOVA | <0.001 | This p-value is from a 2 degree of freedom test to compare differences among the 3 groups. | Mean Difference (Net) | -0.10 | 2-Sided | 95 | -0.57 | 0.37 | Superiority |
2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study |
| Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups. | ANOVA | 0.002 | This p-value is from a 2 degree freedom test of differences among the 3 groups. | Mean Difference (Net) | 0.88 | 2-Sided | 95 | 0.37 | 1.39 | Superiority |
Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups. |
| ANOVA |
| <0.001 |
This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups. |
| Median Difference (Net) |
| 1.40 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.98 |
| Superiority |
| Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms. | ANOVA | 0.24 | This p-value is from the 2 degree of freedom test of differences among the 3 arms. | Mean Difference (Net) | -0.15 | 2-Sided | 95 | -0.32 | 0.02 | Superiority |
Analysis of variance was used to compared mean differences among the 3 groups. |
| ANOVA |
| 0.16 |
This p-value is from a 2 degree of freedom F test. |
| Mean Difference (Net) |
| 2.21 |
| 2-Sided |
| 95 |
| -0.09 |
| 4.51 |
| Superiority |
Analysis of variance was used to compare mean changes among the 3 groups. |
| ANOVA |
| 0.75 |
This p-value is from a 2 degree of freedom test. |
| Mean Difference (Net) |
| 1.44 |
| 2-Sided |
| 95 |
| -2.61 |
| 5.49 |
No significant differences between groups 1 and 3. |
| Superiority |
|
Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups. |
| ANOVA |
| 0.05 |
This p-value is from an F-test to compare differences among the 3 groups. |
| Mean Difference (Net) |
| -1.66 |
| 2-Sided |
| 95 |
| -3.00 |
| -0.32 |
| Superiority |
Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups. |
| ANOVA |
| 0.03 |
This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups. |
| Mean Difference (Net) |
| -1.21 |
| 2-Sided |
| 95 |
| -2.11 |
| -0.30 |
| Superiority |
| Analysis of variance was used to compare differences among the 3 groups. | ANOVA | 0.20 | This p-value is from an analysis of variance comparing all 3 groups. | Mean Difference (Net) | -0.05 | 2-Sided | 95 | -1.45 | 1.35 | The 95% confidence interval for differences between groups 1 and 3 includes 0. | Superiority |
Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.
| ANOVA |
| 0.02 |
This p-value is from a 2 degree of freedom test for differences among the 3 groups. |
| Mean Difference (Net) |
| -0.30 |
| 2-Sided |
| 95 |
| -0.52 |
| -0.08 |
| Superiority |
Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups. |
| ANOVA |
| 0.58 |
This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups |
| Mean Difference (Net) |
| -50 |
| 2-Sided |
| 95 |
| -162 |
| 61 |
| Superiority |
| Mean change in waist girth from baseline to year 2 | ANOVA | 0.001 | The p-value is from a 2 degree of freedom F-test for differences among the 3 arms | Mean Difference (Net) | -2.42 | 2-Sided | 95 | -3.69 | -1.14 | The 95% confidence interval for differences between groups 1 and 3 does not include 0. | Superiority |
| Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups. | Regression, Logistic | No adjustments | 0.004 | 2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms | Odds Ratio (OR) | 2.35 | 2-Sided | 95 | 1.40 | 3.94 | The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0. | Superiority |