Chrononutrition and Adolescent Weight Control

NCT ID: NCT04256863

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2021-04-30

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.

Conditions

Adolescent Obesity; Diet; Weight Loss; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Breakfast / Lunch (BFL)

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.

Group Type: EXPERIMENTAL

Breakfast / Lunch

Intervention Type: BEHAVIORAL

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)

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.

Group Type: ACTIVE_COMPARATOR

Dinner (DIN)

Intervention Type: BEHAVIORAL

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).

Interventions

Breakfast / Lunch

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

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin W Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Jared Saletin, PhD

Role: PRINCIPAL_INVESTIGATOR

The Bradley Hospital

Locations

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin W Evans, PhD

Role: CONTACT

whitney_evans@brown.edu

4017938379

Facility Contacts

E. Whitney Evans, PhD

Role: primary

whitney_evans@brown.edu

401-793-8379

Other Identifiers

U54GM115677

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202819

Identifier Type: -

Identifier Source: org_study_id