NCT04875091

Brief Summary

This study is a single-arm behavioral weight loss intervention for emerging adult women with in-person assessments at 0 (baseline) and 4 months (post-treatment) in addition to EMA data collection regarding risk factors known to interfere with program engagement and weight loss in this high-risk population (e.g., sleep, psychological distress, life events).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

April 30, 2021

Last Update Submit

July 5, 2023

Conditions

Weight LossWeight Change, BodyOverweight or Obesity

Keywords

emerging adultswomenweight loss barriers

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Percent weight change (fasting weight in kg, measured in-person by trained assessors)

    4-months (post-intervention)

Secondary Outcomes (1)

  • Weekly weight change

    4-months (throughout intervention)

Study Arms (1)

Intervention

EXPERIMENTAL
Behavioral: Ready SET Health

Interventions

Ready SET HealthBEHAVIORAL

This behavioral weight loss intervention will span 16 weeks. The first session (Week 1) will be a virtual "Weight Loss 101" group kick-off followed by 15 weeks of a technology-mediated program consisting of the following: weekly emailed content (videos and readings explaining key skills and strategies to produce weight loss) and weekly emailed tailored feedback (based on self-monitoring data from participants). A trained interventionist ("coach") will lead the group session, provide weekly tailored feedback, and monitor participant progress.

Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • BMI (body mass index) 25-45 kg/m2
  • Female gender identity

You may not qualify if:

  • Report of uncontrolled medical condition that may pose a safety issue given the recommendations for the diet and unsupervised physical activity
  • Diagnosed cardiovascular or metabolic disease
  • Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • Recent change in use of medications that may impact weight or metabolic function
  • Cancer in the past 5 years, except non-melanoma skin cancers or early-stage cervical cancer
  • Current symptoms of alcohol or other substance dependence
  • Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months
  • Hospitalization for depression or other psychiatric disorder within the past 12 months
  • Lifetime history of bipolar disorder or psychotic disorder
  • Planning to move from the area within the study period
  • Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 6 months
  • Current involvement in a weight loss program or current use of weight loss medication
  • Recent significant weight loss
  • Inability to read or speak English
  • Lack of a smartphone or unwillingness to use it for study components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Weight LossBody Weight ChangesOverweightObesity

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jessica G LaRose, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 6, 2021

Study Start

July 28, 2021

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)