Trial Outcomes & Findings for Targeting Body Image Among Women of Higher Body Weight (NCT NCT04810247)

Last Updated: 2023-06-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	46
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeting Body Image Among Women of Higher Body Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Body Project Intervention n=46 Participants 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.
Age, Continuous	47.8 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
EDE-Q Shape concern subscale	5.21 units on a scale STANDARD_DEVIATION 0.64 • n=5 Participants
EDE-Q weight concern subscale	4.59 units on a scale STANDARD_DEVIATION 0.76 • n=5 Participants
Internalized weight bias	5.41 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Internalized thin ideal	3.45 units on a scale STANDARD_DEVIATION 0.83 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Completers

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 2 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 3 The Body Project intervention was iteratively revised between each cohort.	Cohort 4 n=8 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 5 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 6 n=8 Participants The Body Project intervention was iteratively revised between each cohort.
EDE-Q Weight and Shape Concern No longer meet enrollment criteria on the weight subscale or on the shape subscale	3 Participants	6 Participants	0 Participants	3 Participants	4 Participants	5 Participants
EDE-Q Weight and Shape Concern No longer meet enrollment criteria for either the shape subscale OR the weight subscale	2 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: Only completers analyzed

Internalized thin ideal is a subscale of the SATAQ-4. Scores can range from 1-5. Higher scores reflect greater internalized thin ideal

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 2 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 3 The Body Project intervention was iteratively revised between each cohort.	Cohort 4 n=8 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 5 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 6 n=8 Participants The Body Project intervention was iteratively revised between each cohort.
Sociocultural Attitudes Towards Appearance Questionnaire-4 Baseline	3.98 score on a scale Standard Deviation 0.67	3.2 score on a scale Standard Deviation 0.86	—	3.2 score on a scale Standard Deviation 0.96	3.26 score on a scale Standard Deviation 0.75	3.6 score on a scale Standard Deviation 1.06
Sociocultural Attitudes Towards Appearance Questionnaire-4 4 week	3.8 score on a scale Standard Deviation 0.85	2.77 score on a scale Standard Deviation 0.96	—	2.85 score on a scale Standard Deviation 0.66	2.86 score on a scale Standard Deviation 1.06	3.55 score on a scale Standard Deviation 0.69

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: Only completers included in analysis

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 2 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 3 The Body Project intervention was iteratively revised between each cohort.	Cohort 4 n=8 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 5 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 6 n=8 Participants The Body Project intervention was iteratively revised between each cohort.
Weight Bias Internalization Scale Baseline	5.84 score on a scale Standard Deviation 0.87	5.09 score on a scale Standard Deviation 1.23	—	5.6 score on a scale Standard Deviation 0.76	5.0 score on a scale Standard Deviation 1.38	5.53 score on a scale Standard Deviation 1.13
Weight Bias Internalization Scale 4 weeks	5.37 score on a scale Standard Deviation 1.11	4.06 score on a scale Standard Deviation 1.39	—	4.75 score on a scale Standard Deviation 1.39	4.21 score on a scale Standard Deviation 1.24	4.56 score on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline and four weeks

Population: Only completers

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 2 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 3 The Body Project intervention was iteratively revised between each cohort.	Cohort 4 n=8 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 5 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 6 n=8 Participants The Body Project intervention was iteratively revised between each cohort.
Momentary Weight and Shape Concern Decreased weight/shape-related negative thoughts	6 Participants	5 Participants	—	7 Participants	6 Participants	6 Participants
Momentary Weight and Shape Concern No change in weight/shape-related negative thoughts	3 Participants	2 Participants	—	0 Participants	1 Participants	1 Participants
Momentary Weight and Shape Concern Increased weight/shape-related negative thoughts	0 Participants	0 Participants	—	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: within 4 weeks of intervention completion

Population: Only completers

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.

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 2 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 3 The Body Project intervention was iteratively revised between each cohort.	Cohort 4 n=8 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 5 n=7 Participants The Body Project intervention was iteratively revised between each cohort.	Cohort 6 n=8 Participants The Body Project intervention was iteratively revised between each cohort.
Qualitative Feedback	8 Participants	6 Participants	—	4 Participants	5 Participants	3 Participants

Adverse Events

Body Project Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. KayLoni Olson

The Miriam Hospital

Phone: 401-793-8971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place