Trial Outcomes & Findings for The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention. (NCT NCT05794763)
NCT ID: NCT05794763
Last Updated: 2024-12-16
Results Overview
Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied. The mean score across the items is reported. Overall scores can range from 1 to 6 and a higher score indicate a greater level of body satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
Body Project: In Person Delivery
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
36
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Body Project: Comparing the Effectiveness of an In-person and Virtually Delivered Intervention.
Baseline characteristics by cohort
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
36 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)Ten items from the Satisfaction and Dissatisfaction with Body Parts Scale assessed satisfaction with body parts with a response scale ranging from 1 = extremely dissatisfied to 6 = extremely satisfied. The mean score across the items is reported. Overall scores can range from 1 to 6 and a higher score indicate a greater level of body satisfaction.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Change Over Time in Body Dissatisfaction
|
.42 score on a scale
Interval 0.1359 to 0.7241
|
0.51 score on a scale
Interval 0.3329 to 0.6871
|
PRIMARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)The eight-item Ideal-Body Stereotype Scale-Revised will assess endorsement of the thin beauty ideal using a response scale ranging from 1 = strongly disagree to 5 = strongly agree. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates a greater level of thin ideal internalization.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Change Over Time in Thin Ideal Internalization
|
-0.64 scale
Interval -1.0115 to -0.2685
|
-0.59 scale
Interval -0.9544 to -0.2256
|
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)Twenty items from the sadness, guilt, and fear/anxiety subscales from the Positive Affect and Negative Affect Scale-Revised will assess negative affect. Participants reported the extent to which they had felt negative emotions on scales ranging from 1 = very slightly or not at all to 5 = extremely. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates a greater level of negative affect.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Change Over Time in Negative Affect
|
-0.17 scale score
Interval -0.64 to 0.3
|
-0.41 scale score
Interval -0.8023 to -0.0177
|
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)The 10-item Dutch Restrained Eating Scale will assess the frequency of dieting behaviors using a response scale ranging from 1 = never to 5 = always. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates greater frequency of dieting behaviors.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Change Over Time in Dieting
|
-0.48 scale score
Interval -0.9445 to -0.0155
|
-0.77 scale score
Interval -1.137 to -0.403
|
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention (after completion of 4 weeks of group session once a week)The six selected items from the Body, Eating, and Exercise Comparison Orientation Scale will assess the frequency of body comparisons using a response scale ranging from 1 = strongly disagree to 5 = strongly agree. The mean score across the items is reported. Overall scores can range from 1 to 5 and a higher score indicates greater frequency of body comparison.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Body Comparison Orientation
|
-0.38 scale score
Interval -0.8272 to 0.0672
|
-0.60 scale score
Interval -1.0454 to -0.1546
|
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention.The 16-item Social Appearance Anxiety Scale will assess levels of social appearance anxiety using a response scale ranging from 1 = not at all to 5 = extremely.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention.The 10-item Body Appreciation Scale-2 will assess levels of body compassion using a response scale ranging from 1 = never to 5 = always.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention.The 10-item Self-Stigma of Seeking Help Scale will assess participants' views towards seeking help using a scale ranging from 1 = strongly disagree to 5 = strongly agree.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre intervention and 3 months after the end of the intervention.Interviewer assesses frequency of eating disorder behaviors using Eating Disorder Diagnostic Interview.
Outcome measures
| Measure |
Body Project: In Person Delivery
n=33 Participants
In the in-person peer-led group intervention, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
Body Project: Virtual Delivery
n=36 Participants
In the virtual peer-led group intervention held over Zoom, participants voluntarily engage in verbal, written, and behavioral exercises in which they critique and discuss the costs of pursuing the thin-ideal ideal. The intervention is 4 sessions long (1-hr each) and is administered by trained peer facilitators who use an intervention script. Participants will be asked to complete weekly home exercises throughout the course of the intervention.
Peer Led Group Intervention: A four-week dissonance-based program where individuals with body image concerns complete verbal, written, and behavioral activities. The program consists of four 60-minute sessions
|
|---|---|---|
|
Number of Eating Disorder Behaviors (Events) as a Measure of Change Over Time in Eating Disorder Symptoms
|
-5.22 events
Interval -11.225 to 0.7852
|
-3.68 events
Interval -9.0126 to 1.6526
|
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention.7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre intervention obtained on intake, and immediately post intervention.7 items assessing attitudes that are targeted as part of The Body Project training using a response scale ranging from 1 = strongly disagree to 5 = strongly agree.
Outcome measures
Outcome data not reported
Adverse Events
Body Project: In Person Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Body Project: Virtual Delivery
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place