Clinical trial NCT05635097: Remote Weight Management Program for Obese Women
Official title: Remote Weight Management Program for Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Weight change (in pounds)
timeFrame: 8 weeks
Secondary outcomes:
measure: Waist circumference change (in inches)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References: