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Remote Weight Management Program for Obese Women

Remote Weight Management Program for Obese Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05635097
Enrollment
30
Registered
2022-12-02
Start date
2023-01-17
Completion date
2023-05-20
Last updated
2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

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.

Interventions

BEHAVIORALMotivational 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).

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Weight change (in pounds)8 weeksWeight of at least 5-10 % per participant from baseline

Secondary

MeasureTime frameDescription
Waist circumference change (in inches)8 weeksAt least 2.5 inches change per participant from baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026