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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this study is to modify the evidence-based Body Project intervention to more powerfully target weight and shape concern among women with BMI between 25-40 using exploratory sequential mixed methodology (using both quantitative and focus group data). Initial modifications to the intervention will be made to incorporate content targeting weight stigma and to ensure the materials are developmentally appropriate for adult women. Then a small group (n=5-10) of women with high weight and shape concern will receive the 4 week body project intervention; we will collect pre-post questionnaire data on weight and shape concern, thin ideal and weight stigma, and use ecological momentary assessment to examine in-the-moment thoughts about weight and shape. The body project intervention will then be revised using this information in combination with participant feedback elicited during a focus group session. The next iteration of the intervention will then be tested in another small group of n=5-10; it is estimated that it will take 4-6 iterations to achieve a more robust intervention program that is acceptable to the target sample. Subgroups (race/ethnicity, BMI class) will be evaluated to ensure suitability across groups.
Women with overweight or obesity, over the age of 25, who report high weight and shape concern and a desire to lose weight will be recruited from the community. Participants will be recruited and enrolled in cohorts of 5-10 individuals, with a focus on ensuring that each group has approximately 50% women of color (i.e., identify as non-white).
Participants will attend, with all individuals in their cohort, the four weekly body project intervention sessions led by a trained facilitator. Each session is approximately 60 minutes long and relies on guided discussion and group activities to engage participants. In between group meetings, participants will be given exercises to complete prior to the next session. The intervention content will be modified prior to the first cohort in order to identify factors relevant for body image among women who would medically benefit from weight loss (e.g., internalized weight bias). The active ingredients will remain the same while modifying content and assignments or exercises to enhance effects among the target population.
Participants will complete a baseline assessment of self-report surveys and a 7-day ecological momentary assessment period. All assessment procedures must be complete prior to the first group meeting. After the fourth and final group meeting, participants will complete a second assessment including self-report surveys and a 7-day EMA period. The data collected from the pre and post-assessments will be used to shape the focus group script. Within four weeks of the last group meeting, participants will attend a focus group meeting led by a facilitator who was not involved in intervention delivery to better understand the participant experience with the intervention content. Key changes may include expanding content to address contextual factors that cause negative weight/shape-related thoughts among women with overweight or obesity and to target weight stigma (internalized), modifying exercises that were reviewed negatively, and incorporating explicit discussion of weight management.
Following the focus group, the intervention will be revised using the quantitative and qualitative data collected from each cohort. The process will be repeated to refine the intervention through iterative testing with small groups of individuals (n≤10). It is anticipated that approximately 4-6 groups will be required. Upon completion of all study procedures, participants will receive information and resources for healthy weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body Project intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Project | Behavioral | The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised for use among adult women with weight/shape concern and higher body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| EDE-Q Weight and Shape Concern | Participants were eligible for the study if they reported a shape concern score greater than or equal to 4.25 and a weight concern score greater than or equal to 4.0. Clinically significant change in weight and shape concern was defined as no longer meeting study eligibility on just one subscale or on both subscale (shape concern score <4.25; weight concern score <4.0). This outcome reports the number of participants who met this clinical milestone and no longer met criteria for enrollment. | 4 weeks |
| Sociocultural Attitudes Towards Appearance Questionnaire-4 | Internalized thin ideal is a subscale of the SATAQ-4. Scores can range from 1-5. Higher scores reflect greater internalized thin ideal | Baseline and 4 weeks |
| Weight Bias Internalization Scale | Internalized weight bias is calculated by taking the average value of the 10-item Weight Bias Internalization Scale (this excludes item 1 consistent with standards in the field). Possible scores range from 1-7. Higher scores reflect greater internalized weight bias. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Momentary Weight and Shape Concern | Participants rated how negative their thoughts were about weight and shape since the previous prompt (on a 0-10 scale) 6 times per day for 7 days at baseline and following treatment. Individual participant responses were presented graphically and coded as representing a general decrease, increase, or no change in negative weight/shape-related thoughts from baseline to 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
The current study is limited to individuals who identify as female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Body Project Intervention | The Body project is an evidence-based intervention designed to target negative body image among adolescent females. This program will be iteratively revised. Body Project: The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Body Project Intervention | The Body project is an evidence-based intervention designed to target negative body image among adolescent females. This program will be iteratively revised. Body Project: The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | EDE-Q Weight and Shape Concern | Participants were eligible for the study if they reported a shape concern score greater than or equal to 4.25 and a weight concern score greater than or equal to 4.0. Clinically significant change in weight and shape concern was defined as no longer meeting study eligibility on just one subscale or on both subscale (shape concern score <4.25; weight concern score <4.0). This outcome reports the number of participants who met this clinical milestone and no longer met criteria for enrollment. | Completers | Posted | Count of Participants | Participants | 4 weeks |
|
6 weeks
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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 | Body Project Intervention | The Body project is an evidence-based intervention designed to target negative body image among adolescent females. This program will be iteratively revised. Body Project: The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised. |
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Cohort 3 was discontinued by the PI due to low engagement. After the first group meeting, only 1 of 5 enrolled individuals was engaged/actively participating. Delivering the intervention one-on-one is not consistent with protocol and the group environment is conceptually an active ingredient of the intervention (and an important component per Focus Group feedback). Therefore, the study team decided to discontinue all study procedures for this group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. KayLoni Olson | The Miriam Hospital | 401-793-8971 | kayloni.olson@lifespan.org |
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| 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 | Dec 31, 2020 | Apr 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Baseline and four weeks |
| Qualitative Feedback | Attendance at focus group. Following the four-week modified Body Project intervention, participants were asked to attend a meeting to provide feedback on their experience in the intervention. | within 4 weeks of intervention completion |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| EDE-Q Shape concern subscale | The Shape concern subscale of the EDE-Q is comprised of the average of 8-items with possible scores ranging from 0-6. Higher scores reflect greater shape concern. | Mean | Standard Deviation | units on a scale |
|
| EDE-Q weight concern subscale | The weight concern subscale of the EDE-Q is comprised of the average of 5-items with possible scores ranging from 0-6. Higher scores reflect greater weight concern. | Mean | Standard Deviation | units on a scale |
|
| Internalized weight bias | Internalized weight bias is calculated by taking the average value of the 10-item Weight Bias Internalization Scale (this excludes item 1 consistent with standards in the field). Possible scores range from 1-7 with higher scores reflecting greater internalized weight bias. | Mean | Standard Deviation | units on a scale |
|
| Internalized thin ideal | Internalized thin ideal is a subscale of the SATAQ-4. It is calculated by taking the average of 5 subscale items and scores can range from 1-5. Higher scores reflect greater internalized thin ideal. | Mean | Standard Deviation | units on a scale |
|
The Body Project intervention was iteratively revised between each cohort. |
| OG002 | Cohort 3 | The Body Project intervention was iteratively revised between each cohort. |
| OG003 | Cohort 4 | The Body Project intervention was iteratively revised between each cohort. |
| OG004 | Cohort 5 | The Body Project intervention was iteratively revised between each cohort. |
| OG005 | Cohort 6 | The Body Project intervention was iteratively revised between each cohort. |
|
|
| Primary | Sociocultural Attitudes Towards Appearance Questionnaire-4 | Internalized thin ideal is a subscale of the SATAQ-4. Scores can range from 1-5. Higher scores reflect greater internalized thin ideal | Only completers analyzed | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks |
|
|
|
| Primary | Weight Bias Internalization Scale | Internalized weight bias is calculated by taking the average value of the 10-item Weight Bias Internalization Scale (this excludes item 1 consistent with standards in the field). Possible scores range from 1-7. Higher scores reflect greater internalized weight bias. | Only completers included in analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks |
|
|
|
| Secondary | Momentary Weight and Shape Concern | Participants rated how negative their thoughts were about weight and shape since the previous prompt (on a 0-10 scale) 6 times per day for 7 days at baseline and following treatment. Individual participant responses were presented graphically and coded as representing a general decrease, increase, or no change in negative weight/shape-related thoughts from baseline to 4 weeks. | Only completers | Posted | Count of Participants | Participants | Baseline and four weeks |
|
|
|
| Secondary | Qualitative Feedback | Attendance at focus group. Following the four-week modified Body Project intervention, participants were asked to attend a meeting to provide feedback on their experience in the intervention. | Only completers | Posted | Count of Participants | Participants | within 4 weeks of intervention completion |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 4 week |
|
| 4 weeks |
|
| No change in weight/shape-related negative thoughts |
|
| Increased weight/shape-related negative thoughts |
|