iDIP: Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2

Sponsor
University of Illinois at Urbana-Champaign (Other)
Overall Status
Completed
CT.gov ID
NCT04605640
Collaborator
(none)
30
1
1
24.5
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weight Management Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Individualized Diet Improvement Program for Weight Loss and Maintenance
Actual Study Start Date :
Mar 26, 2019
Actual Primary Completion Date :
Apr 10, 2021
Actual Study Completion Date :
Apr 10, 2021

Arms and Interventions

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. Participants will be followed by daily self-weighing for 1 year after intervention.

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.

Outcome Measures

Primary Outcome Measures

  1. Body weight [Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month]

    Body weight in kilograms measured on a standard scale (Withings, US)

Secondary Outcome Measures

  1. Waist circumference [Change from baseline (0 month) to 6 month, 12 month, 24 month]

    Waist circumference in centimeters measured using a standard measuring tape

  2. Hip circumference [Change from baseline (0 month) to 6 month, 12 month, 24 month]

    Hip circumference in centimeters measured using a standard measuring tape

  3. Body composition [Change from baseline (0 month) to 6 month, 12 month, 24 month]

    Body fat measured using InBody 270

  4. Body composition [Change from baseline (0 month) to 6 month, 12 month, 24 month]

    muscle mass measured using InBody 270

  5. Protein intake [Change from baseline (0 month) to 12 month]

    Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)

  6. Protein intake [Periodically from baseline (0 month) to 12 month]

    Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record

  7. Fiber intake [Change from baseline (0 month) to 12 month]

    Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)

  8. Fiber intake [Periodically from baseline (0 month) to 12 month]

    Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Urbana-Champaign Urbana Illinois United States 61801

Sponsors and Collaborators

  • University of Illinois at Urbana-Champaign

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mindy Lee, Graduate Research Assistant, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT04605640
Other Study ID Numbers:
  • 18069_cohort2
First Posted:
Oct 28, 2020
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2021