Adolescent ObesityNCT04256863
Chrononutrition and Adolescent Weight Control
A study testing Breakfast / Lunch and Dinner (DIN) in people with Adolescent Obesity and Diet, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Obesity, Diet, Weight Loss
- What is being tested?
- Breakfast / Lunch and Dinner (DIN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2020to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
E. Whitney Evans, PhD, 401-793-8379, whitney_evans@brown.edu
About this study
Official title: Examining the Role of Chrononutrition in Behavioral Weight Control for Adolescents
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.
- Conditions
- Adolescent Obesity, Diet, Weight Loss, Sleep
- Being tested
- Breakfast / Lunch, Dinner (DIN)
- Medical subject headings
- Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast / LunchBehavioural
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. .
Dinner (DIN)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Breakfast / Lunch (BFL) | Experimental | 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. Receives: Behavioral: Breakfast / Lunch |
| Dinner (DIN) | Active comparator | 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. Receives: Behavioral: Dinner (DIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks (mid-intervention)
Adherence
Participant attendance in weekly group-based sessions
Measured: 16-week intervention
Secondary outcomes (3)
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
Measured: Baseline and Immediately after intervention (16 weeks)
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.
Measured: Baseline and Immediately after intervention (16 weeks)
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
Measured: Baseline and Immediately after intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Feb 2020
- Primary completionFeb 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Brown University
- Responsible party
- Sponsor
- Investigators
- Erin W Evans, PhD, Principal investigator, The Miriam HospitalJared Saletin, PhD, Principal investigator, The Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256863
- Sponsor's protocol ID
- 202819
- Other IDs
- U54GM115677
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Chrononutrition in Behavioral Weight Control for Adolescents
- ClinicalTrials.gov ID
- NCT04256863
- Acronym / sponsor ID
- 202819
- Conditions
- Adolescent Obesity, Diet, Weight Loss, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Brown University
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast / Lunch (BFL) | Experimental | Behavioral: Breakfast / LunchThis 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. |
| Dinner (DIN) | Active comparator | Behavioral: Dinner (DIN)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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast / LunchParticipants 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. . | Behavioural | Breakfast / Lunch (BFL) |
| Dinner (DIN)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). | Behavioural | Dinner (DIN) |
Primary outcome
Intervention Feasibility: Percent of energy consumed
Time frame: 3 weeks (mid-intervention)
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
Time frame: 16-week intervention
Participant attendance in weekly group-based sessions
3 secondary outcomes
Change in Body Mass Index z-score (BMIz)
Time frame: Baseline and Immediately after intervention (16 weeks)
Change in Sleep Duration
Time frame: Baseline and Immediately after intervention (16 weeks)
Change in Sleep Quality: proportion of the sleep period spent asleep and not awake
Time frame: Baseline and Immediately after intervention (16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin W Evans, PhD principal investigator
The Miriam Hospital
Jared Saletin, PhD principal investigator
The Bradley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast / Lunch and Dinner (DIN) in people with Adolescent Obesity and Diet, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin W Evans, PhD (4017938379, whitney_evans@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility: Percent of energy consumed (time frame: 3 weeks (mid-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.