EMPOWER Weight Management

NCT04635722 | Unknown

• 1 other identifier: 18069_Empower
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This research is to develop a virtual weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.

Conditions

Obesity; Overweight; Weight Loss; Diet Habit

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight in kilograms measured on a standard scale (Withings, US)

  Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month

Secondary Outcomes (10)

• Waist circumference

  Change from baseline (0 month) to 6 month,12 month, 24 month

• Hip circumference

  Change from baseline (0 month) to 6 month, 12 month, 24 month

• Body composition

  Change from baseline (0 month) to 6 month, 12 month, 24 month

• Body composition

  Change from baseline (0 month) to 6 month, 12 month, 24 month

• Protein Intake

  Change from baseline (0 month) to 12 month

Study Arms (1)

Weight Management Intervention

EXPERIMENTAL

During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. Participants will be followed by daily self-weighing for 1 year after intervention.

Behavioral: Weight Management Intervention

Interventions

Weight Management Intervention BEHAVIORAL

Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.

Weight Management Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index in the overweight or obese range (BMI) \>28 kg/m2 (if Asian, BMI \>25kg/m2);
• not currently pregnant or lactating;
• have Wi-Fi at home, a working email, and an iPhone or Android smartphone;
• self-reported obesity co-morbidities (such as diabetes type 2 or hyperlipidemia);
• be a Carle Foundation Hospital patient and have regular contact with a primary care physician;
• not using insulin injection;
• able to attend the 22 (1 hour) diet improvement sessions;
• willing and safe to lose 20 lb. or more for 6 months and maintain a healthy weight for one year;
• keep weighing their weight for two years;
• fluent in reading and writing English.

You may not qualify if:

• age \<18 or \>75 years;
• body mass index of \<28 kg/m2 (if Asian, BMI \<25kg/m2);
• currently pregnant;
• currently lactating;
• use insulin injection;
• not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
• failed to set up a Wi-Fi scale;
• failed to submit a FFQ.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

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: Graduate Research Assistant

Model Details: Before and after study design with one interventional group and no control or placebo group

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: June 11, 2021
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)