Alternative Dietary Approaches Online to Promote Tracking

NCT05049005 | Completed

• 1 other identifier: 20-0491
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Compare the efficacy of two 3-month Internet-based interventions that use a simplified strategy for monitoring of dietary intake among young adult men and women with overweight or obesity. Participants: Young adult men and women who are between the ages of 18-35 years (N=75) and who currently have overweight or obesity (BMI between 25 and 50 kg/m\^2). Procedures (methods): This is a randomized controlled trial comparing the efficacy of two Internet-based dietary interventions among 75 young adult men and women who currently have overweight or obesity. Both interventions will use simplified monitoring of dietary intake using an approach based on the Traffic Light Diet. One intervention will target a reduction in intake of red foods (high-calorie, high-fat foods) and tracking of red foods in the study website. The other intervention will target an increase in intake of green foods (low-calorie, healthy foods) and tracking of green foods in the study website. Components of both interventions include (1) personalized goals for red/green food intake, (2) weekly tailored feedback, and (3) weekly lessons delivered via smartphone.

Conditions

Diet Quality; Weight Loss

Keywords

Adherence, diet tracking, diet goals

Outcome Measures

Primary Outcomes (2)

• Adherence to dietary tracking

  Adherence will be assessed via frequency of dietary monitoring. Each food entry will be time-stamped and automatically captured by the study website interface. Frequency of dietary monitoring will be defined as the total number of days during the 3-month intervention that participants tracked breakfast or lunch AND dinner, which will be considered a full (versus partial) day of tracking.

  3 months

• Adherence to dietary goals

  Adherence will be measured as the total number of full days of tracking (i.e. breakfast or lunch AND dinner) during which participants met their dietary goal. Non-adherence will be assumed for partial days of tracking, or days where participants did not track.

  3 months

Secondary Outcomes (3)

• Percent weight loss

  3 months

• Change in Dietary intake

  Baseline, Month 3

• Change in Diet quality

  Baseline, Month 3

Other Outcomes (4)

• Change in Restraint, Disinhibition, Hunger

  Baseline, Month 3

• Change in Self-Regulation (eating behaviors)

  Baseline, Month 3

• Change in Self-Regulation (global)

  Baseline, Month 3

Study Arms (2)

RED FOOD Intervention Group

ACTIVE COMPARATOR

Participants in the RED FOOD group will be taught a simplified way of identifying high-calorie foods (red foods) and reducing them using the Traffic Light Diet. Limiting the number of red foods consumed is a simple way to reduce calories without having to track calories. Participants in this group will use the study website to track their red foods and will be given a daily red food limit base on their baseline weight and will track their red foods on the study website daily. Participants will be recommended to enter their red foods at least once per day (at which time they would enter all red foods for the day), but ideally multiple times per day to reduce errors associated with recall.

Behavioral: Simplified dietary tracking

GREEN FOOD Intervention Group

EXPERIMENTAL

Participants in the GREEN FOOD group will be taught a simplified way of identifying low-calorie foods (green foods) and maximizing them using the Traffic Light Diet. Maximizing the number of green foods consumed is a simple way to reduce dietary energy density while allowing for consumption of a satisfying amount (i.e. weight and volume) of food. Maximizing green food consumption may simultaneously reduce red food consumption, thereby reducing calorie intake and promoting greater diet quality than red food reduction alone. Participants in this group will also use the study website to track their green foods and will be given a daily green food goal based on their baseline weight and will track their green foods on the study website daily. Participants will be recommended to enter their green foods at least once per day (at which time they would enter all green foods for the day), but ideally multiple times per day to reduce errors associated with recall.

Behavioral: Simplified dietary tracking

Interventions

Simplified dietary tracking BEHAVIORAL

Mobile-delivered nutrition program using simplified dietary monitoring with a focus on weight loss.

GREEN FOOD Intervention Group; RED FOOD Intervention Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) between 25 and 50 kg/m\^2
• English-speaking and writing
• Own a smartphone with an active data and text messaging plan
• Own a bathroom scale or willing to purchase a bathroom scale prior to the study start date
• Willing to be randomized to either group

You may not qualify if:

• Type I or Type 2 diabetes
• Currently participating in another nutrition or weight loss program
• Lost 10 or more pounds (and kept it off) in the last 6 months
• Currently taking weight loss medications
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant in the next 6 months
• Serious current physical disease (i.e. heart disease, stroke, cancer, or renal disease) for which physician supervision of diet and exercise prescription is needed
• Physical problems that limit the ability to exercise daily
• History of clinically diagnosed eating disorder
• Report a past diagnosis of or current symptoms of alcohol or substance dependence
• Diagnosis of schizophrenia or bipolar disorder
• Hospitalization for a psychiatric diagnosis within the last year
• Currently living with another study participant

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Weight Research Program

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julianne M Power, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: October 4, 2021
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)