Remote Weight Management Program for Obese Women

Study Overview
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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.

Official Title
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Remote Weight Management Program for Obese Women

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a clinical diagnosis of obesity (BMI ≥30 kg/m2), Age of 18 years or older, English-speaking participants with access to a smartphone device 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: Must not be taking medications specifically for weight loss or currently participating in a weight loss program, Must not be pregnant or breast-feeding, Women without a clinical diagnosis of obesity (BMI < 30 kg/m2) Must not have lost >3 kg body weight or dramatically changed physical activity patterns within the past six months, Clinical diagnosis of eating disorders Clinical diagnosis of uncontrolled hypertension or neurological or psychological disorders Must not have any obesity-related surgery within the past six months (i.e., gastric bypass).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One group intervention<br>One group without comparator | Behavioral: Motivational Interviewing counseling on the Mediterranean diet and weight checks at regular intervals<br>* 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).<br>|

What is the study measuring?
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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 |