Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2

Obesity Clinical Trial

— iDIP  

Official title:

Individualized Diet Improvement Program for Weight Loss and Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605640
• Other study ID #: 18069_cohort2
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: April 10, 2021

Study information

• Verified date: July 2021
• 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: Completed
• Enrollment: 30
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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; 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 two years; fluent in reading and writing English.

Exclusion Criteria:

age <18 or >70 years; body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2); currently pregnant; currently lactating; self-reported with 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 FFQ.

Related Conditions & MeSH terms

• Body Weight
• Diet Habit
• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Weight Management Intervention
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.

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 measured on a standard scale (Withings, US)	Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Secondary	Waist circumference	Waist circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Hip circumference	Hip circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Body composition	Body fat measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Body composition	muscle mass measured using InBody 270	Change from baseline (0 month) to 6 month, 12 month, 24 month
Secondary	Protein intake	Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Secondary	Protein intake	Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record	Periodically from baseline (0 month) to 12 month
Secondary	Fiber intake	Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Secondary	Fiber intake	Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record	Periodically from baseline (0 month) to 12 month