Clinical trial NCT04605640: Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2
Official title: Individualized Diet Improvement Program for Weight Loss and Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Diet Habit
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Hip circumference
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Body composition
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Body composition
timeFrame: Change from baseline (0 month) to 6 month, 12 month, 24 month
measure: Protein intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Protein intake
timeFrame: Periodically from baseline (0 month) to 12 month
measure: Fiber intake
timeFrame: Change from baseline (0 month) to 12 month
measure: Fiber intake
timeFrame: Periodically from baseline (0 month) to 12 month
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: