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Knowledge-based Dietary Weight Management.

Primary Purpose

Weight Loss, Dietary Modifications, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight management
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Eligible participants will be in an intervention group led by a registered dietitian

Outcomes

Primary Outcome Measures

Body weight
Body weight in kilograms
Body weight
Body weight in kilograms
Body weight
Body weight in kilograms

Secondary Outcome Measures

Waist circumference
Waist circumference in centimeters
Hip circumference
Hip circumference in centimeters
Protein intake
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Protein intake
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Fiber intake
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
Fiber intake
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal

Full Information

First Posted
April 15, 2020
Last Updated
April 16, 2020
Sponsor
University of Illinois at Urbana-Champaign
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1. Study Identification

Unique Protocol Identification Number
NCT04353726
Brief Title
Knowledge-based Dietary Weight Management.
Official Title
Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Dietary Modifications, Obesity, Sustainability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Eligible participants will be in an intervention group led by a registered dietitian
Intervention Type
Other
Intervention Name(s)
Weight management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight in kilograms
Time Frame
Change from baseline body weight at 6 months
Title
Body weight
Description
Body weight in kilograms
Time Frame
Change from baseline body weight at 12 months
Title
Body weight
Description
Body weight in kilograms
Time Frame
Change from baseline body weight at 18 months
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Waist circumference in centimeters
Time Frame
Change from baseline waist circumference at 12 months
Title
Hip circumference
Description
Hip circumference in centimeters
Time Frame
Change from baseline hip circumference at 12 months
Title
Protein intake
Description
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Time Frame
Change from baseline protein intake at 6 months
Title
Protein intake
Description
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Time Frame
Change from baseline protein intake at 12 months
Title
Fiber intake
Description
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
Time Frame
Change from baseline fiber intake at 6 months
Title
Fiber intake
Description
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
Time Frame
Change from baseline fiber intake at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nakamura T Manabu, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data that underlie results in a publication will be shared.
IPD Sharing Time Frame
Data will be maintained for three years after completion of the study
IPD Sharing Access Criteria
Findings will be disseminated via abstracts and presentations at scientific conferences and through manuscripts and journal articles within the field.

Learn more about this trial

Knowledge-based Dietary Weight Management.

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