Remote Weight Management Program for Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: One group intervention; One group without comparator

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change (in pounds)	Weight of at least 5-10 % per participant from baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference change (in inches)	At least 2.5 inches change per participant from baseline	8 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 00002292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depends on positive/negative results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No