Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source Yeshiva University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Intuitive Eating Treatment
Participants received a brief web-based intervention for disordered eating which focused on a style of eating behavior called "intuitive eating". Please see arm description for more details.

Locations

Country Name City State
United States Study was conducted exclusively online Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Yeshiva University

Country where clinical trial is conducted

United States, 

Outcome

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)
See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT05526235 - A Scalable Psychological Intervention to Reduce Psychological Distress Among Workers of Assisted Living Facilities N/A
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03720600 - Forms of Racial Discrimination Study N/A
Not yet recruiting NCT05400096 - Psychological Wellbeing in Clients in Tier 3 Weight Management Service N/A
Completed NCT02212236 - Psychological Intervention for Distress During HSCT Phase 2
Active, not recruiting NCT00892138 - Mindfulness Training for Stress Management N/A
Recruiting NCT04815278 - NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations N/A
Recruiting NCT04936828 - Ecological Momentary Intervention for Stroke Caregivers' Psychological Support N/A
Withdrawn NCT03341364 - Acceptance and Commitment Based Group Therapy for Cancer Patients N/A
Recruiting NCT05137925 - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum N/A
Completed NCT04376723 - Mental Health Apps for Mild Psychological Distress Amongst Adolescents N/A
Active, not recruiting NCT04020497 - Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients N/A
Terminated NCT03587896 - Implementation of Self Help Plus in Adult Syrian Refugees in Turkey (RE-DEFINE) N/A
Not yet recruiting NCT03652168 - Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees Phase 3
Completed NCT03721770 - Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation
Recruiting NCT05849454 - Messy Memories: Mobile Application Therapy Following Critical Illness N/A
Recruiting NCT05525299 - Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors N/A
Recruiting NCT06052904 - Music Breathing for Caregivers of Children Newly Diagnosed With Cancer N/A