Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DK128561 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BWLI-College | Experimental | BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement. |
|
| Control | Active Comparator | The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BWLI-College | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | 10 weeks |
| Percentage of Participants Who Remained at 10 Weeks | Rate of retention of 80% or more (benchmark) | 10 weeks |
| Adherence | Average attendance and completion of sessions of 75% or more (benchmark) | 10 weeks |
| Weight Change | Average weight loss of at least 3% (benchmark) | 10 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline F Hayes, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02903 | United States |
Individual participant data will not be made available to share with other researchers.
Not provided
Not provided
Not provided
Not provided
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.
Recruitment in this trial followed college semesters, starting in Summer 2023 and ending in Fall 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BWLI-College | BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement. BWLI-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. |
| FG001 | Control | The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention. Control: Psychoeducation around dieting myths, healthy eating, and physical activity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BWLI-College | BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement. BWLI-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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Acceptability | 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. | Posted | Mean | Standard Deviation | score | 10 weeks |
|
from enrollment until end of follow-up, up to 10 weeks
Collection approach was non-systematic for initial cohorts and a questionnaire (systematic) process was added.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BWLI-College | BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement. BWLI-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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment initiation or change | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Hayes, phD | The Miriam Hospital | 4017938917 | jhayes3@brownhealth.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2024 | Dec 19, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Control | Behavioral | Psychoeducation around dieting myths, healthy eating, and physical activity |
|
| BG001 | Control | The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention. Control: Psychoeducation around dieting myths, healthy eating, and physical activity |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Weight Category | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention. |
|
|
| Primary | Percentage of Participants Who Remained at 10 Weeks | Rate of retention of 80% or more (benchmark) | Posted | Count of Participants | Participants | 10 weeks |
|
|
|
| Primary | Adherence | Average attendance and completion of sessions of 75% or more (benchmark) | Posted | Mean | Standard Deviation | percent sessions attended | 10 weeks |
|
|
|
| Primary | Weight Change | Average weight loss of at least 3% (benchmark) | Posted | Mean | Standard Deviation | percent change | 10 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | Control | The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention. Control: Psychoeducation around dieting myths, healthy eating, and physical activity | 0 | 5 | 0 | 5 | 2 | 5 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |