Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01HL153783 | U.S. NIH Grant/Contract | View source | |
| R03HL171171 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Teens consume more added sugar than any other age group. Too much added sugar is associated with poor diet quality, obesity risk, and negative cardiometabolic outcomes. Behavioral interventions to improve dietary intake are needed, but are currently lacking for this age group. This study aims to test how feasible, acceptable, and effective a 12-week contextually-tailored health coaching program, called Sip & Snack Better (SSB), is in reducing added sugar in teens, compared to a technology-only comparison. It will provide important information on how to improve dietary intake and reduce added sugar in teens. Additionally, measuring diet is very challenging in teens, so this study will also test the use of an objective biomarker (called the carbon isotope ratio (CIR)) as a measure of added sugar intake before, during, and after the 12-week study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Coaching Behavioral Intervention | Experimental | Behavioral intervention using health coaching and technology to improve dietary intake |
|
| Technology-Only Comparison | Other | Digitally-delivered nutrition education only comparison arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sip & Snack Better (SSB) Intervention | Behavioral | Participants (teens 12-16 years) and their parent or legal guardian will participate in a 12-week health coaching intervention to reduce added sugar intake. Parents and teens will participate in 6 health coaching sessions (in weeks 1, 3, 5, 7, 9, and 12; 30-45 minutes, online via Zoom). Teens will participate in four in-person groups sessions (in weeks 2, 4, 6, and 8) and receive text-messages to reinforce intervention content. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Added Sugar Intake | Change in added sugar intake will be assessed using the carbon isotope ratio (CIR) as a objective measure of added sugar intake via breath, blood, and hair samples taken at baseline and post-intervention. Intent-to-treat analyses will be conducted using linear regression models to examine changes in CIR between intervention and control participants. A lower (i.e., more negative) CIR value indicates lower added sugar intake. | Baseline to 12-weeks |
| Intervention Feasibility | Feasibility will be assessed by session attendance (>75%) and retention (>80%) over the 12-week study. | Baseline to 12-weeks |
| Intervention Acceptability | Participants will report acceptability (>80% rating of 4 or 5 on Likert scale questions) on a post-intervention acceptability questionnaire | Baseline to 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Diet Quality | Changes in diet quality will be assessed via Healthy Eating Index (HEI) derived from three 24-hour dietary recalls at baseline and post-intervention. HEI is scored on a scale from 0 to 100 with higher scores indicating higher diet quality. | Baseline to 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Breath CIR | Feasibility of breath CIR to capture intervention adherence will be assessed via completion rates of breath samples (>80%). The sampling protocol collects three breath samples on five random sampling days at baseline and in weeks 3, 6, 9, and 12 (15 total breath samples over 12-weeks). | Baseline to 12-weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Obesity Research and Education | Philadelphia | Pennsylvania | 19140 | United States |
Not provided
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C436317 | RBM14 protein, human |
| C506261 | SSB protein, human |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sip & Snack Better (SSB) Tech-Only Comparison | Other | Participants (teens 12-16 years) and their parent or legal guardian will participate in a 12-week technology-only comparison arm. Parents and teens will receive information about added sugar intake and healthy eating once via email or text message (based on preference) in weeks 1, 3, 5, 7, 9, and 12. Teens will receive informational text messages 3 times per week . |
|
| Predictive Accuracy of the Carbon Isotope Ratio (CIR) as an indicator of Added Sugar and Sugar Sweetened Beverage Intake |
Area under the curve (AUC) models will be used to determine how well each CIR sample type (blood, breath, hair, nails) captured changes in added sugar and sugar-sweetened beverage intake (derived from 24-hour dietary recalls). AUC ranges from 0 -1 and a higher AUC indicates better model fit. |
| Baseline to 12-weeks |
| CIR Biomarker Acceptability | Participants will report on a scale of 1-5 how anxious or stressed they are before the collection (1= Very stressed or anxious, 5= Not at all stressed or anxious). After collection, participants will report on a scale of 1-5 how comfortable they felt during the collection (1= very uncomfortable, 5= very comfortable) and how difficult or burdensome they found the collection method (1=very difficult or very burdensome, 5=not at all difficult or burdensome). After all data are collected participants will rank the collection methods in order of preference (1= top choice, 4= last choice) and report (yes/no) if they would be willing to provide each type again in a subsequent study (breath, blood, hair, nail). | Baseline to 12-weeks |