Obesity
Conditions
Brief summary
This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. The primary aim of this study is maximize student acceptability of the intervention and weight loss outcomes.
Detailed description
Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This proof-of-concept study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.
Interventions
BEHAVIORALBWLI-College
Behavioral modifications are based on empirically-supported principles for weight loss. Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention. Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each participant.
BEHAVIORALControl
Psychoeducation around dieting myths, healthy eating, and physical activity
Sponsors
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The first 3 cohorts of this study were a single group pre-post design. Based on findings from those, the fourth cohort was changed to include a control group (arm 2). A control group was not originally planned until the next phase of the study; however, it was included at this stage in order to put achievement of weight benchmarks into context and inform potential progression decision-making.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* BMI of 25 or greater * Enrolled at college/university where study will take place * English-speaking
Exclusion criteria
* History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires) * Participation in another formal weight loss program * Current or recent pregnancy * Psychiatric hospitalization in the past 12 months * Recent weight loss of 5% body weight or more * History of bariatric surgery * Severe food or physical activity restrictions that would interfere with treatment recommendations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 10 weeks | Refers to the satisfactory nature of a treatment and will be assessed via the 4-item Acceptability of Intervention Measure. Benchmarks are to reach mean scores of at least 4 out of 5. Range is 1 to 5, with higher scores indicating greater acceptability. |
| Percentage of Participants Who Remained at 10 Weeks | 10 weeks | Rate of retention of 80% or more (benchmark) |
| Adherence | 10 weeks | Average attendance and completion of sessions of 75% or more (benchmark) |
| Weight Change | 10 weeks | Average weight loss of at least 3% (benchmark) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacqueline F Hayes, PhD
Brown University
Participant flow
Recruitment details
Recruitment in this trial followed college semesters, starting in Summer 2023 and ending in Fall 2024.
Pre-assignment details
While 42 signed the consent, n=6 were unable to participate due to their scheduling (i.e., their schedule did not allow for them to participate at the selected time) and n=2 were lost to follow-up prior to initiating treatment and learning of treatment condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 2 Participants |
| Weight Category Obese | 27 Participants |
| Weight Category Overweight | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 5 |
| other Total, other adverse events | 3 / 29 | 2 / 5 |
| serious Total, serious adverse events | 0 / 29 | 0 / 5 |
Outcome results
None listed