Psychological Distress Clinical Trial
— IERCTOfficial title:
A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
NCT number | NCT05031611 |
Other study ID # | 20200516 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2020 |
Est. completion date | March 17, 2021 |
Verified date | August 2021 |
Source | Yeshiva University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating. Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).
Status | Completed |
Enrollment | 123 |
Est. completion date | March 17, 2021 |
Est. primary completion date | September 2, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Female - Between 18 and 30 years of age - Located in the United States or Canada - No eating disorder - No previous participation in an intuitive eating intervention - Score greater than or equal to 25 on the TFEQ-r18 at baseline Exclusion Criteria: - Gender not female - Younger than 18 years of age - Older than 30 years of age - Located outside the United States or Canada - Score less than 25 on the TFEQ-r18 at baseline - Previously participated in an intuitive eating intervention - Current eating disorder |
Country | Name | City | State |
---|---|---|---|
United States | Study was conducted exclusively online | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Yeshiva University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intuitive Eating | Intuitive eating was measured by the Intuitive Eating Scale, 2nd edition (IES-2). Scores on this scale range from 1 to 5, with higher scores indicating greater levels of Intuitive Eating. | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Primary | Disordered Eating | Revised Three Factor Eating Questionnaire (TFEQ-r18) | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Secondary | Body Appreciation | Body appreciation was measured by the Body Appreciation Scale, 2nd edition (BAS-2). Scores on this scale range from 13 to 65, with higher scores indicating greater levels of body appreciation. | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Secondary | Dichotomous Thinking Around Food | Dichotomous thinking around food was measured by the Dichotomous Thinking Scale (DT). Scores on this scale range from 11 to 44, with higher scores indicating greater levels of dichotomous thinking around food. | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Secondary | Psychological Flexibility | Psychological flexibility was measured by the Acceptance and Action Questionnaire, 2nd edition (AAQ-2). Scores on this scale range from 7 to 49, with higher scores indicating greater psychological flexibility. | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Secondary | Food Intake | Food intake was measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data on respondents' food intake. Participants are asked to recall the frequency in which they consumed various food items over the past 3 days. Frequencies are grouped by food type (i.e., vegetables, fruits, dairy, etc.) and summed. | Baseline (Time 1) through study completion, 10 weeks (Time 2) | |
Secondary | Body Mass Index (BMI) | Weight/Height used to calculate BMI | Baseline (Time 1) through study completion, 10 weeks (Time 2) |
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