A Small Changes Weight Loss Program and Message Dissemina... | NCT03614338

Studies
A Small Changes Weight Loss Program and Message Dissemination Via Facebook in Chicago's West Side

NCT03614338

Sponsor

Rush University Medical Center

Status

Completed

Last Update Posted

Aug 19, 2019Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Small changes weight loss program

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

Aug 2019

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

Jan 3, 2019Actual

Primary Completion Date

May 8, 2019Actual

Completion Date

Aug 15, 2019Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Aug 2, 2018

First Posted Date

Aug 3, 2018Actual

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

Aug 15, 2019

Last Update Posted Date

Aug 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melissa M. Crane, PhD, Assistant Professor, Rush University Medical CenterPrincipal Investigator

Lead Sponsor

Rush University Medical CenterOTHER

Collaborators

Not provided

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

African-American communities experience a greater burden of obesity-related diseases such as type 2 diabetes mellitus and cardiovascular disease and higher rates of obesity, compared to other race groups. There is a need for interventions that show promise in mitigating these disparities. The primary goal of this project is to pilot test whether an existing "small-changes" intervention for weight loss can be modified and delivered within the West Side ALIVE churches.

Detailed Description

Not provided

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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Core Participants Weight Loss Program	Experimental	Small changes weight loss program	Behavioral: Small changes weight loss program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Small changes weight loss program	Behavioral	This intervention uses a "small-changes" approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight	Change from baseline using objectively measured body weight	3 months

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Change from baseline	3 months
Physical activity	Change from baseline in total minutes of MVPA assessed by accelerometer

Other Outcomes

Measure	Description	Time Frame
Program satisfaction	Self-reported program satisfaction post-intervention	3 months
Program engagement	Number of sessions attended during intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 25-45 kg/m2
Age 18-75
Attend one of the West Side partnership churches at least 2 times per month
Able to attend in-person meetings
Willing to share their experiences on the West Side ALIVE Facebook page

Exclusion Criteria:

Blood pressure > 170/90 (self-report or during the WSA screening)
Diabetes treated with insulin
History of cancer within the past 5 years
Pregnancy or breastfeeding in the last 6 months, planning to become pregnant in the next 3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	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
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided