Background
Weight gain in young adults
Prior trials for weight gain prevention in young adults
Novel interventions for weight gain prevention
Study aims
Methods
Study design
Eligibility
Inclusion criteria | |
• BMI 21 – 30 kg/m2
| |
• 18 – 35 years of age | |
• Willing to be randomized to any of the three conditions | |
Exclusion criteria | |
• Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider | |
• Unable to walk for physical activity | |
• Report of any of the following health problems: heart condition, chest pain during periods of activity or rest, loss of consciousness, diabetes treated with insulin or medications that may cause hypoglycemia, active tuberculosis, HIV, acromegaly, Cushing’s syndrome, 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 | |
• Past diagnosis of or treatment for anorexia nervosa or bulimia nervosa or meet criteria for anorexia or bulimia nervosa during screening | |
• Past diagnosis of or current symptoms of alcohol/substance dependence | |
• Currently pregnant, trying to get pregnant, pregnant within last 6 months | |
• History of schizophrenia, manic depression, or bipolar disorder | |
• Hospitalization for depression or other psychiatric disorder in past 12 months | |
• Lost and maintained 10 pounds or more within the past 6 months, participating in a weight loss program, taking weight loss medication, or have had surgery for weight loss | |
• Participation in another weight loss or physical activity study | |
• Another member of the household 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 | |
• Not able to speak and understand English | |
• Residence or place of work further than 50 miles from the intervention site | |
• Perceived inability to attend the 2 year data collection visit | |
• No Internet access on a regular basis |
Recruitment
Randomization
Self-guided behavior changes (Control condition)
Active interventions: common components
Time frame | Meetings | Reporting weight |
---|---|---|
Year 1 | ||
Months 1-2 | Weekly face-to-face (8 total) | None* |
Months 3-4 | Monthly face-to-face (2 total) | Weekly |
Months 5-12 | None | Monthly |
Year 2 | Two annual 4 week refreshers: offered in different formats (face-to-face; online; email) | Monthly |
Year 3 | Two annual 4 week refreshers: offered in different formats (face-to-face; online; email) | Monthly |
Intervention contact
Self-regulation
Basic information about self-weighing, healthy eating and physical activity
Behavior modification skills
Active interventions: differences between the two active interventions
Key intervention concepts | Small changes | Large changes |
---|---|---|
Dietary changes recommended for maintaining weight (green zone) | Instructed to make one small change in diet every day (roughly equivalent to 100 calories) | Start with 1200–1800 kcal/day diet to create weight loss buffer in first 8 weeks. After buffer created, gradually increase caloric intake until maintaining weight loss, but continue to consume low calorie, low fat healthy diet |
Physical activity changes recommended for maintaining weight (green zone) | Given pedometers and instructed to increase steps by 2000 steps per day over baseline levels and maintain this level | Instructed to exercise to 250 min/week (50 min/day on 5 days/week) throughout the entire program. |
Self-monitoring of behavior changes | During first 16 weeks and during refresher courses, record number of steps per day and check off whether or not a small change in diet was made every day. Self-monitor weight daily throughout the entire program. | Self-monitor food intake (calories and fat grams) for first 16 weeks of the program, throughout the refresher course, and if they experience weight regain. Self-monitor weight daily throughout the entire program. |
What to do if regain 1 pound or more above the weight they achieve at the end of the initial 8 week program and enter yellow zone, but remain at or below baseline | Taught to resume self-monitoring of steps and small changes to diet. Use problem-solving skills, with an emphasis on changing surrounding environment to support small changes. | Taught to resume self-monitoring of food intake for several days to help identify problem areas and get back on track. Use problem-solving skills, with an emphasis on changing surrounding environment to support large changes. |
What to do if exceed baseline or starting weight (red zone) | Instructed to implement additional small change(s) in both eating and exercise (e.g. make at least 1 small change at each meal, each day and increase steps by 3000 over baseline level). | Instructed to reinitiate large changes – return to 1200–1800 kcal/day diet, continue 250 min/week of activity, and self-monitor intake and activity until they are back in the green zone. |
Self-regulation plus small behavior changes
Week | Small changes | Large changes |
---|---|---|
1 | Small changes, big rewards: a self-regulation approach to controlling your weight | Lose a little now to get big rewards later: a self-regulation approach to controlling your weight |
2 | Moving more: increasing your physical activity | Healthy diet |
3 | Small changes in your diet: decreasing how much you eat | Moving more: taking time for physical activity |
4 | Making small changes in your diet that will work for you: changing what you eat | Cues in your environment |
5 | Small steps for big benefits | Eating out |
6 | The slippery slope of eating out | Problem solving |
7 | Liquid calories: what’s in your glass | Maintaining an exercise routine |
8 | Putting it all together | Putting it all together |
Self-regulation plus large behavior changes group
Outcome measures
Measure | Month | |||||
---|---|---|---|---|---|---|
0 | 4 | 12 | 24 | 36 | 48 | |
Anthropomorphic | ||||||
Weight (primary outcome) | X | X | X | X | X | X |
Height | X | X | X | X | X | X |
Waist circumference | X | X | X | X | X | X |
Body composition with impedance | X | X | X | X | X | X |
Body composition with BodPod (UNC only) | X | X | X | X | X | X |
Behavioral and cognitive | ||||||
Diet (Food Frequency Questionnaire) | X | X | X | |||
Specific questions about diet | X | X | X | X | X | X |
Physical activity: Paffenbarger | X | X | X | X | X | X |
Sedentary activity | X | X | X | X | X | X |
Objective (arm bands) | X | X | X | X | ||
Weight history | X | |||||
Weight management strategies | X | X | X | X | X | X |
Self-weighing | X | X | X | X | X | X |
Eating disorders assessment | X | X | X | X | X | X |
Eating inventory | X | X | X | X | X | X |
Autonomous motivation | X | X | X | X | X | X |
Smoking, alcohol use | X | X | X | X | X | X |
Sleep habits | X | X | X | X | X | X |
Neighborhood, environment | X | X | X | X | X | X |
Medical | ||||||
Blood pressure | X | X | X | X | X | X |
Fasting lipids, glucose, insulin | X | X | ||||
Medication use | X | X | X | X | X | X |
Medical events | X | X | X | X | X | |
DNA, serum, plasma | X | X | ||||
Psychological assessments | ||||||
Depression (CES-D) | X | X | X | X | X | X |
Life events | X | X | X | X | X | X |
Perceived stress | X | X | X | X | X | X |
Quality of life | X | X | X | X | X | X |
Other questionnaires | ||||||
Demographic data | X | X | X | X | X | X |
Contact information | X | X | X | X | X | X |
Weight status of friends and family | X | X | X | X | X | X |
Treatment preference, satisfaction and post-treatment feedback | X | X | X | X | X | X |
Adherence (Intervention groups only) | ||||||
Attendance at adherence sessions | Throughout | |||||
Monthly submission of weight data | Throughout |