Remote Weight Management Program for Obese Women

Weight Loss Clinical Trial

Official title:

Remote Weight Management Program for Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635097
• Other study ID #: 00002292
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: May 20, 2023

Study information

• Verified date: May 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals
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).

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change (in pounds)	Weight of at least 5-10 % per participant from baseline	8 weeks
Secondary	Waist circumference change (in inches)	At least 2.5 inches change per participant from baseline	8 weeks