Clinical trial NCT04353726: Knowledge-based Dietary Weight Management.
Official title: Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Dietary Modifications
Obesity
Sustainability
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study design
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:

* 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

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline body weight at 6 months
measure: Body weight
timeFrame: Change from baseline body weight at 12 months
measure: Body weight
timeFrame: Change from baseline body weight at 18 months
Secondary outcomes:
measure: Waist circumference
timeFrame: Change from baseline waist circumference at 12 months
measure: Hip circumference
timeFrame: Change from baseline hip circumference at 12 months
measure: Protein intake
timeFrame: Change from baseline protein intake at 6 months
measure: Protein intake
timeFrame: Change from baseline protein intake at 12 months
measure: Fiber intake
timeFrame: Change from baseline fiber intake at 6 months
measure: Fiber intake
timeFrame: Change from baseline fiber intake at 12 months
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Nakamura T Manabu, PhD
role: PRINCIPAL_INVESTIGATOR
References: