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

Not Applicable

Completed

• Conditions: Obesity; Overweight; Diet Habit; Weight Loss

• Registration Number: NCT04605640
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Body weight	Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month	Body weight in kilograms measured on a standard scale (Withings, US)

Secondary Outcome Measures

Name	Time	Method
Body composition	Change from baseline (0 month) to 6 month, 12 month, 24 month	muscle mass measured using InBody 270
Protein intake	Periodically from baseline (0 month) to 12 month	Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record
Hip circumference	Change from baseline (0 month) to 6 month, 12 month, 24 month	Hip circumference in centimeters measured using a standard measuring tape
Waist circumference	Change from baseline (0 month) to 6 month, 12 month, 24 month	Waist circumference in centimeters measured using a standard measuring tape
Fiber intake	Periodically from baseline (0 month) to 12 month	Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record

Trial Locations

Locations (1)

University of Illinois at Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States