Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 1 (iDIP)

Individualized Diet Improvement Program 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: Completed
• Conditions: Obesity; Overweight; Weight Loss; Diet Habit
• Intervention / Treatment: Behavioral: Weight Management Intervention

• Study Type: Interventional
• Enrollment (Actual): 14
• 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:

• 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Weight Management Intervention; 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.

Behavioral: Weight Management Intervention; Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight in kilograms measured on a standard scale (Weight Gurus, Greater Goods LLC, MO)	Change from baseline (0 month) to 6 month, 12 month, and 18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 12 month
Hip circumference	Hip circumference in centimeters measured using a standard measuring tape	Change from baseline (0 month) to 12 month
Protein intake	Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Protein intake	Protein intake in grams and grams/100 kilo-calories using a 24-hour food record	Periodically from baseline (0 month) to 12 month
Fiber intake	Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)	Change from baseline (0 month) to 12 month
Fiber intake	Fiber intake in grams and grams/100 kilo-calories using a 24-hour food record	Periodically from baseline (0 month) to 12 month

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2018
• Primary Completion (ACTUAL): July 28, 2019
• Study Completion (ACTUAL): July 28, 2019

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (ACTUAL): October 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 18069_cohort1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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