Understanding Variability in Behavioral Weight Loss Treat... | NCT04875091

Studies
Understanding Variability in Behavioral Weight Loss Treatment Response in Young Women (Ready SET Health)

NCT04875091

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Jul 6, 2023Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Weight Loss
Weight Change, Body
Overweight or Obesity

Interventions

Ready SET Health

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2021Actual

Primary Completion Date

Jun 20, 2023Actual

Completion Date

Jun 20, 2023Actual

First Submitted Date

Apr 30, 2021

First Submission Date that Met QC Criteria

Apr 30, 2021

First Posted Date

May 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2023

Last Update Posted Date

Jul 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

This study will implement a 4-month Internet-based behavioral weight loss intervention in order to collect ecological momentary assessment (EMA) data that will shed light on real-time barriers to weight management. The intervention is evidence-based and adapted with respect to content and delivery mode in order to meet the needs of emerging adult women. Consenting and eligible participants will receive 1 virtual group session led by a trained interventionist followed by weekly emails directing them to an intervention website housing video and .pdf content, weekly text messages, emailed tailored feedback regarding their weight loss behaviors and progress, and a closed Facebook group to facilitate social support. All participants will be followed for 4 months with hybrid in-person/virtual assessments at 0 and 4 months; in addition, all participants will be asked to respond to EMA prompts throughout the 4-month intervention period (Week 2, Week 4, Week 7, and Week 13).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Behavioral: Ready SET Health

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ready SET Health	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight change	Percent weight change (fasting weight in kg, measured in-person by trained assessors)	4-months (post-intervention)

Secondary Outcomes

Measure	Description	Time Frame
Weekly weight change	Weekly weight change (weight in lbs obtained through participants' Bluetooth-/wireless-connected study scale; converted to kg for analyses)	4-months (throughout intervention)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-25 years of age
BMI (body mass index) 25-45 kg/m2
Female gender identity

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Female gender identity

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jessica G LaRose, PhD	Virginia Commonwealth University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D044343	Overnutrition

Browse Leaves

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Browse Branches

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