Remote Weight Management Program for Obese Women

NCT ID: NCT05635097

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2023-05-20

Brief Summary

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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

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One group intervention

One group without comparator

Group Type OTHER

Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Noel Bairey Merz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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00002292

Identifier Type: -

Identifier Source: org_study_id

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