Knowledge-based Dietary Weight Management.

NCT04353726 | Unknown

• 1 other identifier: 18069
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Dietary Modifications; Obesity; Sustainability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Waist circumference

  Change from baseline waist circumference at 12 months

• Hip circumference

  Change from baseline hip circumference at 12 months

• Protein intake

  Change from baseline protein intake at 6 months

• Protein intake

  Change from baseline protein intake at 12 months

• Fiber intake

  Change from baseline fiber intake at 6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Other: Weight management

Interventions

Weight management OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nakamura T Manabu, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Model Details: Before and after study design

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: September 5, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be maintained for three years after completion of the study
• Access Criteria: Findings will be disseminated via abstracts and presentations at scientific conferences and through manuscripts and journal articles within the field.

Locations

US (1)