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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04353726
Other study ID # 18069
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 5, 2017
Est. completion date April 2021

Study information

Verified date April 2020
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is to develop a 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion criteria:

- age 18-64 years;

- body mass index (BMI) >28 kg/m2;

- not currently pregnant or lactating;

- have Wi-Fi at home, a working email, and an iPhone or Android smartphone.

- no self-reported severe metabolic, cardiovascular or musculoskeletal disease;

- not using insulin injection;

- able to attend the 22 (1 hour) diet improvement sessions.

- willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year.

- keep weighing their weight for one and a half years.

- fluent in reading and writing English.

Exclusion criteria:

- age <18 or >64 years;

- body mass index of <28 kg/m2;

- currently pregnant;

- currently lactating;

- self-reported with the severe metabolic, cardiovascular or musculoskeletal disease;

- 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 food frequency questionnaire

Study Design


Intervention

Other:
Weight management
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.

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight Body weight in kilograms Change from baseline body weight at 6 months
Primary Body weight Body weight in kilograms Change from baseline body weight at 12 months
Primary Body weight Body weight in kilograms Change from baseline body weight at 18 months
Secondary Waist circumference Waist circumference in centimeters Change from baseline waist circumference at 12 months
Secondary Hip circumference Hip circumference in centimeters Change from baseline hip circumference at 12 months
Secondary Protein intake Protein intake in grams and caloric intake will be combined to report density in g/100kcal Change from baseline protein intake at 6 months
Secondary Protein intake Protein intake in grams and caloric intake will be combined to report density in g/100kcal Change from baseline protein intake at 12 months
Secondary Fiber intake Fiber intake in grams and caloric intake will be combined to report density in g/100kcal Change from baseline fiber intake at 6 months
Secondary Fiber intake Fiber intake in grams and caloric intake will be combined to report density in g/100kcal Change from baseline fiber intake at 12 months
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