Knowledge-based Dietary Weight Management.

Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Weight Loss; Dietary Modifications; Sustainability
• Intervention / Treatment: Other: Weight management

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois at Urbana-Champaign

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; Eligible participants will be in an intervention group led by a registered dietitian

Other: Weight management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in kilograms	Change from baseline body weight at 6 months
Body weight	Body weight in kilograms	Change from baseline body weight at 12 months
Body weight	Body weight in kilograms	Change from baseline body weight at 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference in centimeters	Change from baseline waist circumference at 12 months
Hip circumference	Hip circumference in centimeters	Change from baseline hip circumference at 12 months
Protein intake	Protein intake in grams and caloric intake will be combined to report density in g/100kcal	Change from baseline protein intake at 6 months
Protein intake	Protein intake in grams and caloric intake will be combined to report density in g/100kcal	Change from baseline protein intake at 12 months
Fiber intake	Fiber intake in grams and caloric intake will be combined to report density in g/100kcal	Change from baseline fiber intake at 6 months
Fiber intake	Fiber intake in grams and caloric intake will be combined to report density in g/100kcal	Change from baseline fiber intake at 12 months

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Nakamura T Manabu, PhD, University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 18069 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No