Remote Weight Management Program for Obese Women

NCT05635097 | Completed

• 1 other identifier: 00002292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight change (in pounds)

  Weight of at least 5-10 % per participant from baseline

  8 weeks

Secondary Outcomes (1)

• Waist circumference change (in inches)

  8 weeks

Study Arms (1)

One group intervention

OTHER

One group without comparator

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

Interventions

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

One group intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 2, 2022
• Study Start: January 17, 2023
• Primary Completion: April 7, 2023
• Study Completion: May 20, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

US (1)