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Remote Weight Management Program for Obese Women

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women with a clinical diagnosis of obesity (BMI ≥30 kg/m2), Age of 18 years or older, English-speaking participants with access to a smartphone device At least one cardiovascular risk factor (at least one clinical diagnosis of the following conditions: hypertension, dyslipidemia, type 2 diabetes, pre-diabetes, sleep apnea, family history of heart disease, cigarette smoking, inactivity, preeclampsia, gestational diabetes, gestational hypertension, preterm birth, rheumatological diseases, or premature menopause). Exclusion Criteria: Must not be taking medications specifically for weight loss or currently participating in a weight loss program, Must not be pregnant or breast-feeding, Women without a clinical diagnosis of obesity (BMI < 30 kg/m2) Must not have lost >3 kg body weight or dramatically changed physical activity patterns within the past six months, Clinical diagnosis of eating disorders Clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders Must not have any obesity-related surgery within the past six months (i.e., gastric bypass).

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

One group intervention

Arm Description

One group without comparator

Outcomes

Primary Outcome Measures

Weight change (in pounds)
Weight of at least 5-10 % per participant from baseline

Secondary Outcome Measures

Waist circumference change (in inches)
At least 2.5 inches change per participant from baseline

Full Information

First Posted
November 10, 2022
Last Updated
May 31, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05635097
Brief Title
Remote Weight Management Program for Obese Women
Official Title
Remote Weight Management Program for Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the research project is to see if counseling on the Mediterranean diet combined with motivational interviewing via a telemedicine platform (Zoom) while using smart technology ("smart" scales and tape) improves participants' weight loss, reduces waist circumference, and improves satisfaction with their care.
Detailed Description
The investigators will evaluate a formal remote weight management and follow-up program, utilizing a technology-based intervention using the Renpho application paired with a smart scale and smart tape measure. The primary communication technologies will be the REDCap and Zoom platforms. Renpho's smart body fat scale and tape measure are health applications that sync with fitness applications such as Apple Health, MyFitnessPal, Fitbit, and Samsung Health. The Renpho Bluetooth-enabled smart scale and smart tape devices will allow participants to sync with the Renpho application on their smartphone to automatically upload data such as weight, BMI, and WC to their phone. The project leader will review participants' self-reported weights and WC fortnightly. The participants will be asked to complete a post-participation satisfaction survey that includes a 5-point scale ("strongly agree", "agree", "neutral", "disagree:", to "strongly disagree") Likert-style questions. Expected Outcomes. The primary outcomes for this eight-week intervention are to achieve a clinically significant reduction in weight of at least 5-10 % and at least 2.5 inches reduction in WC per participant from baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One group intervention
Arm Type
Other
Arm Description
One group without comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals
Intervention Description
Each participant will meet virtually on Zoom with the DNP project leader and receive 1:1 counseling on pairing the Repnho smart scale and tape measure with the Renpho application. The expectations of the weight management program will be explained in detail during the first session, which will last one hour (session one= week zero). The weight loss goal will be at least 1-2 pounds per week as recommended by the Centers for Disease Control and Prevention (CDC) (2022).
Primary Outcome Measure Information:
Title
Weight change (in pounds)
Description
Weight of at least 5-10 % per participant from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Waist circumference change (in inches)
Description
At least 2.5 inches change per participant from baseline
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with a clinical diagnosis of obesity (BMI ≥30 kg/m2), Age of 18 years or older, English-speaking participants with access to a smartphone device At least one cardiovascular risk factor (at least one clinical diagnosis of the following conditions: hypertension, dyslipidemia, type 2 diabetes, pre-diabetes, sleep apnea, family history of heart disease, cigarette smoking, inactivity, preeclampsia, gestational diabetes, gestational hypertension, preterm birth, rheumatological diseases, or premature menopause). Exclusion Criteria: Must not be taking medications specifically for weight loss or currently participating in a weight loss program, Must not be pregnant or breast-feeding, Women without a clinical diagnosis of obesity (BMI < 30 kg/m2) Must not have lost >3 kg body weight or dramatically changed physical activity patterns within the past six months, Clinical diagnosis of eating disorders Clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders Must not have any obesity-related surgery within the past six months (i.e., gastric bypass).
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depends on positive/negative results

Learn more about this trial

Remote Weight Management Program for Obese Women

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