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Not listed Not applicable Interventional Accepts healthy volunteers

Chrononutrition and Adolescent Weight Control

ClinicalTrials.gov ID: NCT04256863

Public ClinicalTrials.gov record NCT04256863. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Examining the Role of Chrononutrition in Behavioral Weight Control for Adolescents

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Comprehensive lifestyle interventions are recommended for the treatment of adolescent obesity; however, evidence suggests that they are not as effective in teens as they are in children and adults. Recent evidence supports that shifting the timing of energy intake earlier in the day has led to improved weight loss outcomes among adults with overweight and obesity. Given that adolescents traditionally consume the majority of their daily energy intake late in the day (past 5PM), this approach may improve the effectiveness of traditional behavioral weight control interventions in teens. Therefore, the primary aim of the proposed research is to pilot a novel adaptation of an evidence-based adolescent weight control intervention in which adolescents will be randomized to consume the majority of their daily energy needs earlier versus later in the day. More specifically, 40 adolescents, ages 13-17, with obesity (BMI\>95% for age and sex) will be randomized to a 16-week evidence-based weight control intervention that has the participant consume \>50 percent of their total energy intake before 3PM (i.e. at breakfast / lunch; BFL) or after 3PM (i.e. dinner; DIN). Assessments will take place at baseline and 16 weeks (post-treatment). The proposed study will test 1) the adherence and feasibility of the BFL vs. DIN interventions as measured by the average number of days on which daily energy was consumed in accordance with the prescribed eating plan and, secondarily, mean session attendance, 2) if the BFL group will have significantly greater reductions in BMI post-treatment as compared to the DIN group, 3) if there are differences in sleep duration and quality between groups, and finally, as an exploratory aim, whether there are differences in dietary quality between groups. The proposed research is significant, as it addresses obesity in teens. It is innovative as the timing of meals and snacks have not been manipulated in adolescents in the context of behavioral weight control. Moreover, the study will shed light on whether doing so improves sleep and could help to untangle how sleep and weight gain relate in adolescents.

Study identification

NCT ID
NCT04256863
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
The Miriam Hospital
Other
Enrollment
40 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
13 Years to 17 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 14, 2020
Primary completion
Jan 31, 2021
Completion
Mar 31, 2021
Last update posted
Sep 1, 2020

2020 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Weight Control and Diabetes Research Center Providence Rhode Island 02903 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04256863, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 1, 2020 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04256863 live on ClinicalTrials.gov.

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