Knowledge-based Dietary Weight Management.

Obesity Clinical Trial

Official title:

Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353726
• Other study ID #: 18069
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Body Weight
• Dietary Modifications
• Obesity
• Sustainability
• Weight Loss

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