Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating

NCT03612661 | Completed

• 1 other identifier: HM20012263
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to pilot test a new intervention that helps young adult women learn adaptive eating and exercise strategies, increase their body acceptance, decrease unhealthy weight control behaviors and prevent future eating and problems. This intervention is experimental, and the study will test its feasibility, acceptability, and effectiveness.

Conditions

Disordered Eating Behaviors

Keywords

disordered eating, body image, intuitive eating, undergraduates, college, unhealthy weight control behaviors, eating disorders, weight stigma, weight bias

Outcome Measures

Primary Outcomes (3)

• Change in diagnostic eating disorder symptoms

  The Eating Disorder Diagnostic Scale (EDDS) is a brief self-report measure that screens for the presence of subthreshold or threshold levels of ED symptoms. It yields a symptom composite score, to be used as the primary outcome measure. Items assessing body dissatisfaction, overvaluation of shape/weight, and impairment are measured on a 0 to 6-point scale with higher ratings indicating greater body dissatisfaction. Items evaluating the presence of compensatory behaviors and binge eating are rated yes/no and participants indicate the frequency these behaviors have occurred in the prior 3 months.

  Baseline to 16 weeks

• Change in global eating disorder symptoms

  The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days. Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day. Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days. Higher EDE-Q scores indicate greater eating pathology.

  Baseline to 16 weeks

• Changes in intuitive eating

  The Intuitive Eating Scale-2 (IES-2) is a 23-item self-report measure of intuitive eating with three subscales: Unconditional Permission to Eat, Eating for Physical Rather Than Emotional Reasons, and Reliance on Hunger and Satiety Cues. Items are rated on a 1 to 5-point scale with higher scores indicating higher levels of intuitive eating.

  Baseline to 16 weeks

Secondary Outcomes (7)

• Change in body appreciation

  Baseline to 16 weeks

• Changes in dietary restraint

  Baseline to 16 weeks

• Changes in body functionality appreciation

  Baseline to 16 weeks

• Changes in interoceptive awareness

  Baseline to 16 weeks

• Changes in intuitive exercise

  Baseline to 16 weeks

Study Arms (2)

Intuitive Eating Group Intervention

EXPERIMENTAL

Intuitive eating intervention delivered in a group format with 8-10 women, led by 2 facilitators.

Behavioral: Group Intervention

Intuitive Eating Guided Self-Help

EXPERIMENTAL

Participants in this condition engage in 8 weeks of self-study of the intuitive eating intervention have \~20 minute weekly phone call with a study interventionist.

Behavioral: Guided Self-Help

Interventions

Group Intervention BEHAVIORAL

Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions. They will complete homework between sessions to reinforce learning. The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.

Intuitive Eating Group Intervention

Guided Self-Help BEHAVIORAL

Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (\~20 minutes each). Interventionists will review homework assignments, answer questions, and reinforce adherence. The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.

Intuitive Eating Guided Self-Help

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not currently pregnant
• Enrolled in postsecondary education at VCU
• Have body image or eating concerns

You may not qualify if:

• Eating disorder threshold risk
• Men
• Pregnant women

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Disordered Eating Behavior; Feeding and Eating Disorders; Weight Prejudice

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior

Study Officials

• Suzanne Mazzeo, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either a group or guided self-help condition, of the same intervention, intuitive eating, of the same duration (8 weeks).

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: September 14, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)