Trials / Unknown
UnknownNCT04256863
Chrononutrition and Adolescent Weight Control
Examining the Role of Chrononutrition in Behavioral Weight Control for Adolescents
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- The Miriam Hospital · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. . |
| 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). |
Timeline
- Start date
- 2020-02-15
- Primary completion
- 2021-02-01
- Completion
- 2021-04-01
- First posted
- 2020-02-05
- Last updated
- 2020-09-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04256863. Inclusion in this directory is not an endorsement.