Remote Weight Management Program for Obese Women

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Behavioral: Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals

• Registration Number: NCT05635097
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Study Start: 2023-01-17
• Primary Completion: 2023-04-07
• Status Verified: 2023-05
• Study Completion: 2023-05-20
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women with a clinical diagnosis of obesity (BMI ≥30 kg/m2),
2. Age of 18 years or older,
3. English-speaking participants with access to a smartphone device
4. 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

1. Must not be taking medications specifically for weight loss or currently participating in a weight loss program,
2. Must not be pregnant or breast-feeding,
3. Women without a clinical diagnosis of obesity (BMI < 30 kg/m2)
4. Must not have lost >3 kg body weight or dramatically changed physical activity patterns within the past six months,
5. Clinical diagnosis of eating disorders
6. Clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders
7. Must not have any obesity-related surgery within the past six months (i.e., gastric bypass).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One group intervention	Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals	One group without comparator

Primary Outcome Measures

Name	Time	Method
Weight change (in pounds)	8 weeks	Weight of at least 5-10 % per participant from baseline

Secondary Outcome Measures

Name	Time	Method
Waist circumference change (in inches)	8 weeks	At least 2.5 inches change per participant from baseline

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States