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Chrononutrition and Adolescent Weight Control

Primary Purpose

Adolescent Obesity, Diet, Weight Loss

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breakfast / Lunch
Dinner (DIN)
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Obesity

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 13- 17 years
  • BMI > 85th percentile for age and sex
  • Ability to speak, read and write English due to the group format of the intervention
  • A caregiver who is willing to participate in four separate parent groups with a facilitator
  • Agreement to study participation and random assignment.

Exclusion Criteria:

  • Current involvement in another weight loss program or has lost 10 pounds in the six months prior to enrollment
  • Medical condition that interferes with the prescribed dietary plan or participation in physical activity (e.g. cardiovascular disease, type 1 or 2 diabetes mellitus, or pregnancy)
  • In treatment for or are diagnosed with a major psychiatric disorder, including an eating disorder, at the time of screening
  • Taking medications that promote weight gain.

Sites / Locations

  • Weight Control and Diabetes Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breakfast / Lunch (BFL)

Dinner (DIN)

Arm Description

This group will complete a 16-week standard behavioral weight control intervention in which they will be asked to consume >50% of their daily energy goal before 3PM. To do so, they will complete weekly experiential learning sessions in conjunction with the SBT lessons.

This group will complete a 16-week standard behavioral weight control intervention. They will not be given any recommendations regarding the timing of their energy consumption, but instead encouraged to follow the same energy goals at the BFL group.

Outcomes

Primary Outcome Measures

Intervention Feasibility: Percent of energy consumed
Percent of energy consumed before 3PM (BFL) or after 3PM (DIN) will be measured using data from weekly diet records from weeks 8, 9, and 10. During these three weeks, the interventionist will determine the number of days that each participant consumed >50% of their daily calories in accordance with their prescribed eating plan (before 3PM (BFL) or after 3PM (DIN)). Thus, each participant will receive a score out of total possible 21 days.
Adherence
Participant attendance in weekly group-based sessions

Secondary Outcome Measures

Change in Body Mass Index z-score (BMIz)
Change in BMIz, which will be calculated based on height and weight measurements collected at baseline and 16-weeks (end of intervention) assessments
Change in Sleep Duration
Participants will wear actigraphs and complete a sleep-log at baseline and at the end of the intervention to measure sleep duration, which is the number of minutes between sleep onset and rise time scored sleep.
Change in Sleep Quality: proportion of the sleep period spent asleep and not awake
Participants will wear actigraphs and complete a sleep-log at baseline and at the end of the intervention to measure sleep quality, which is defined as the proportion of the sleep period spent asleep and not awake

Full Information

First Posted
January 30, 2020
Last Updated
August 31, 2020
Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04256863
Brief Title
Chrononutrition and Adolescent Weight Control
Official Title
Examining the Role of Chrononutrition in Behavioral Weight Control for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of General Medical Sciences (NIGMS), Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Diet, Weight Loss, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breakfast / Lunch (BFL)
Arm Type
Experimental
Arm Description
This group will complete a 16-week standard behavioral weight control intervention in which they will be asked to consume >50% of their daily energy goal before 3PM. To do so, they will complete weekly experiential learning sessions in conjunction with the SBT lessons.
Arm Title
Dinner (DIN)
Arm Type
Active Comparator
Arm Description
This group will complete a 16-week standard behavioral weight control intervention. They will not be given any recommendations regarding the timing of their energy consumption, but instead encouraged to follow the same energy goals at the BFL group.
Intervention Type
Behavioral
Intervention Name(s)
Breakfast / Lunch
Intervention Description
Participants in the BFL group will participate in 16 weekly, group based sessions weekly sessions in which they will be exposed to standard behavioral therapy (SBT) for weight control. Each 90-minute session will cover one weight control topic (self-monitoring, modifying the home food environment, physical activity, goal setting, stimulus control, stress-related eating, motivation, problem solving, healthy eating on a budget, social influences and weight loss maintenance) and an experiential learning activity. These hands-on activities will help teens build skills to adhere to 1) their calorie goal (1,400 - 1,600 calories/day) and 2) the prescribed timing for consumption (>50% of their energy needs consumed before 3PM every day of the week. Sample meal plans will be provided to help with adherence. .
Intervention Type
Behavioral
Intervention Name(s)
Dinner (DIN)
Intervention Description
Participants randomized to the Dinner (DIN) group will participate in the same 16-week intervention as those in the BFL group; however, the topics covered in the experiential learning session will pertain to skills needed to adhere to prescribed calorie goals NOT to timing. They will be instructed to consume >50% of their energy needs after 3PM daily.; however, given that most teens consume the bulk of their calories after 5PM, the focus will be on general calorie goals vs. timing., Teens in this group will also be provided sample meal plans that outline how to spread out their calorie intake across breakfast (200), lunch (300), after school snack (200 calories), Dinner (700 calories), after dinner snack (200 calories for 1,600 calorie diet only).
Primary Outcome Measure Information:
Title
Intervention Feasibility: Percent of energy consumed
Description
Percent of energy consumed before 3PM (BFL) or after 3PM (DIN) will be measured using data from weekly diet records from weeks 8, 9, and 10. During these three weeks, the interventionist will determine the number of days that each participant consumed >50% of their daily calories in accordance with their prescribed eating plan (before 3PM (BFL) or after 3PM (DIN)). Thus, each participant will receive a score out of total possible 21 days.
Time Frame
3 weeks (mid-intervention)
Title
Adherence
Description
Participant attendance in weekly group-based sessions
Time Frame
16-week intervention
Secondary Outcome Measure Information:
Title
Change in Body Mass Index z-score (BMIz)
Description
Change in BMIz, which will be calculated based on height and weight measurements collected at baseline and 16-weeks (end of intervention) assessments
Time Frame
Baseline and Immediately after intervention (16 weeks)
Title
Change in Sleep Duration
Description
Participants will wear actigraphs and complete a sleep-log at baseline and at the end of the intervention to measure sleep duration, which is the number of minutes between sleep onset and rise time scored sleep.
Time Frame
Baseline and Immediately after intervention (16 weeks)
Title
Change in Sleep Quality: proportion of the sleep period spent asleep and not awake
Description
Participants will wear actigraphs and complete a sleep-log at baseline and at the end of the intervention to measure sleep quality, which is defined as the proportion of the sleep period spent asleep and not awake
Time Frame
Baseline and Immediately after intervention (16 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 13- 17 years BMI > 85th percentile for age and sex Ability to speak, read and write English due to the group format of the intervention A caregiver who is willing to participate in four separate parent groups with a facilitator Agreement to study participation and random assignment. Exclusion Criteria: Current involvement in another weight loss program or has lost 10 pounds in the six months prior to enrollment Medical condition that interferes with the prescribed dietary plan or participation in physical activity (e.g. cardiovascular disease, type 1 or 2 diabetes mellitus, or pregnancy) In treatment for or are diagnosed with a major psychiatric disorder, including an eating disorder, at the time of screening Taking medications that promote weight gain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin W Evans, PhD
Phone
4017938379
Email
whitney_evans@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin W Evans, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jared Saletin, PhD
Organizational Affiliation
The Bradley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. Whitney Evans, PhD
Phone
401-793-8379
Email
whitney_evans@brown.edu

12. IPD Sharing Statement

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Chrononutrition and Adolescent Weight Control

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