Using Tailored mHealth Strategies to Promote Weight Management Among Adolescent and Young Adult Cancer Survivors

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• Obesity 6,296
• Neoplasms 9,365
• Motor Activity 2,426

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 240 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.

Study arms

• Experimental
  Intervention

  Intervention participants will receive a theory-based mHealth intervention that includes personalized nutrition and physical activity goals, psychoeducation, and evidence-based behavioral skills training delivered via a mobile web app with active content during the first 6 months, provision of digital tools to facilitate self-monitoring (a smart scale and physical activity tracker), an individual video kick-off session, text messages, and access to a closed social networking group with moderated prompts from study staff to foster peer support. Participants are encouraged to log in to web app daily to interact with self-monitoring and behavioral guidance instruction, activities, and feedback.

  Behavioral: AYA WELL Intervention

• Active comparator
  Self-Guided

  Self-guided participants will receive digital tools (a smart scale and activity tracker), an individual video kick-off session, quarterly informational newsletters, and a moderated but non-prompted (by study staff) closed social networking group to enable peer support.

  Behavioral: Self-Guided

Interventions

• BehavioralAYA WELL Intervention

  Behavioral weight management intervention for adolescent and young adult cancer survivors with digital tools, smartphone web app behavioral program, text messages, and expert-guided closed social networking group for peer support.

• BehavioralSelf-Guided

  Self-guided intervention with digital tools, periodic informational support, and moderated social networking group for peer support.

Primary outcomes

1. Weight change percent

   Change in weight (%) from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for in person assessments. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100.

   Time frame: Baseline to 6 months

Secondary outcomes

1. Weight maintenance percent

   Weight will be objectively measured on a digital scale in the participant's home for remote participants and in the clinic for clinic subsample. Percent weight change at 6 months is calculated as ((weight (kg) at 6 months - weight (kg) at baseline)/(weight (kg) at baseline))\*100. Maintenance of weight change is measured from 6 to 12 months.

   Time frame: 6 to 12 months

2. Body Mass Index (BMI)

   Change in body mass index is calculated as weight in kg divided by the square of height in meters. BMI is calculated at each weight assessment and change over time is assessed.

   Time frame: Baseline up to 12 months

3. Health-related quality of life

   Change in health-related quality of life is measured using the Medical Outcomes Study 36-Item Short Form (SF-36) survey. This survey includes 36 items with eight subscales (physical functioning, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions). Responses are coded on a scale of 0 to 100, where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

4. Diet quality

   Diet Quality id assessed using the Healthy Eating Index (HEI) using data from the National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA-24). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome. Participants complete a weekday and weekend day recall at baseline, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

5. Device-measured physical activity

   Change in physical activity is measured as a sum of weekly minutes of light and moderate-to-vigorous physical activity at 6 and 12 months compared to baseline, assessed via wrist-worm Fitbit device. Participants are asked to wear the Fitbit device for a one week during each assessment period at baseline, 6, and 12 months. Change in weekly active minutes will be assessed over time.

   Time frame: Baseline up to 12 months

6. Self-reported physical activity

   Physical activity will be assessed using the Paffenbarger Physical Activity Questionnaire (PAQ) which assesses leisure-time activity. The PAQ provides an estimate of minutes per week of moderate-to-vigorous intensity, and calories/week of light (5 kcal/min), medium (7.5 kcal/min), and high (10 kcal/min) intensity activities. PAQ changes have been predictive of weight change. The measure is administered at baseline, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

7. Frailty Index

   Frailty will be assessed among all participants with a Frailty Index (all participants) Five items assess self-reported fatigue (from SF-36), weight loss, morbidities, difficulty with ambulation (PROMIS Global Health), and ability to overcome resistance (from SF-36).181 The number of positive responses for these components is summed to create the FRAIL index (range 0-5). A value \> 3 is considered frail, and a value of 2 is considered prefrail. Frailty is measured at baseline, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

8. Frailty Phenotype

   Frailty will be assessed in a subset of participants assessed in person with a modified Fried frailty phenotype. The modified Fried frailty phenotype includes five clinically derived factors: 1) weakness (sitting dominant hand-grip strength using hand-held dynamometer and BMI-specific cut points); 2) slowness (timed 15-foot walk); 3) sarcopenia (relative mass of =1.5 SDs below age-, sex-, race-specific values from NHANES using bioelectrical impedance analysis; 4) exhaustion (vitality subscale of SF-36; and 5) low energy expenditure (\<383 kcal/week for males, \< 270 kcal/week for females from Paffenbarger Physical Activity Questionnaire). Individuals with 3 factors are classified as frail and those with 2 factors as pre-frail. Frailty is measured at baseline, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

9. p16 Expression

   Peripheral blood will be collected from a subset of participants assessed in-person. Samples will be used to measure expression of T lymphocyte p16. At each assessment, a whole blood sample of 8mL will be drawn and collected into a 8mL ACD tube. From the ACD tube, analysis of p16 expression will be measured using a TaqMan quantitative reverse-transcription polymerase chain reaction (RTPCR) performed by Sapere Bio (Research Triangle Park, NC). The measure is collected at baseline, 6, and 12 months and change over time will be assessed.

   Time frame: Baseline up to 12 months

10. Biomarkers of cardiovascular disease

    Fasting blood samples (after an overnight fast of at least 8 hours) will be collected from a subset of participants assessed in person. At each assessment, a whole blood sample (collected in one 8.5 mL SST tube) will be collected, processed to serum, and analyzed by LabCorp for lipids (total cholesterol, HDL-C, LDL-C and triglycerides), glucose, and insulin levels. The measures are collected at baseline, 6, and 12 months and change over time will be assessed.

    Time frame: Baseline up to 12 months

11. Blood pressure

    Blood pressure will be assessed in a subset of participants assessed in person with a calibrated blood pressure monitor. Cuff size will be determined by arm circumference. After a 5-minute rest period and with both feet flat on floor, three readings will be taken, with 60 seconds between measurements. The measurement is collected at baseline, 6, and 12 months and change in systolic and diastolic blood pressure will be assessed over time.

    Time frame: Baseline up to 12 months

12. Waist circumference

    Waist circumference will be assessed in a subset of participants assessed in person, measured at the midpoint between highest point of iliac crest and lowest point of costal margin using a Gulik tape measure and following a standard protocol. Two measures of waist circumference are taken; if the difference exceeds 0.5 cm, a third measure is taken. The measurement is collected at baseline, 6, and 12 months and change over time will be assessed.

    Time frame: Baseline up to 12 months

13. Body composition assessed by Air Displacement Plesthymography

    Body composition assessed in a subset of participants with the BodPod (COSMED USA, Inc.). Participants are asked to fast for 8 hours (including caffeine) and to refrain from strenuous exercise for 8 hours prior to these body composition measures. Outcome variable of interest is change in the ratio of lean muscle mass to fat mass. The measurement is collected at baseline, 6, and 12 months and change in the ratio of lean muscle mass to fat mass is assessed over time.

    Time frame: Baseline up to 12 months

14. Accelerometer measured physical activity

    Physical activity will be assessed among the subset of participants completing in-person assessments using ActiGraph accelerometers (GT3X+, Pensacola, FL), which provides an objective assessment to corroborate self-report PA and sedentary activity data. Participants will be instructed to wear the device at all times for a full week; monitoring for at least 600 min/day for at least 5 days in the week (including at least one weekday and one weekend day) is considered adequate for analysis. Data will be aggregated into sedentary, light and MVPA using standard thresholds. Physical activity with accelerometer will be assessed at baseline, 6, and 12 months.

    Time frame: Baseline up to 12 months

Other outcomes

1. Depressive Symptoms

   The Center for Epidemiological Studies Depression Scale (CES-D) will be used to examine levels of depressive symptoms. The CES-D is a self-report scale designed to measure depression symptoms in the general population. The self-test measure includes 20 items that relate to depressive feelings and behaviors during the past week. Items are scored on a range of 0 (rarely or none of the time) to 3 (most or all of the time) with values ranging from 0 to 60. Higher values indicate more depressive symptoms. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

2. Perceived Stress

   The 10-item Perceived Stress Scale (PSS-10) measures overall perceived stress during the past month. Items are scored on a 5-point Likert scale from 0 (Never) to 4 (Very Often) with total scores ranging from 0 to 40. Items 4, 5, 7 and 8 are reverse scored. Higher scores indicate higher levels of perceived stress. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

3. Anxiety

   The Generalized Anxiety Disorder 7-item scale (GAD-7) is a self-report measure of generalized anxiety symptoms.183 Possible scores range from 0 to 21, with higher scores reflecting greater symptom severity; cut-points of 5, 10, and 15 correspond to mild, moderate, and severe levels of anxiety. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

4. Global Health

   The patient-reported outcomes measurement information system (PROMIS) Global Health measure be used to measure perceptions of health. The PROMIS measure consists of 10 self-reported global health items, which assess 5 domains: physical function, pain, fatigue, emotional distress, and social health. The response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher values indicate better health. The measure is administered at baseline, 3, 6, and 12 months and change over time is assessed.

   Time frame: Baseline up to 12 months

5. Competence

   Change in perceived competence from baseline to 3, 6 and 12 months as measured using the Perceived Competence for Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in the subscale (diet and physical activity). Competence is a hypothesized mediator in this study.

   Time frame: Baseline up to 12 months

6. Relatedness

   Relatedness will be measured with 3 items adapted from the 8-item Relatedness subscale of the Basic Need Satisfaction at Work Scale. Examples include "The program demonstrates caring about me as a person" and are scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived relatedness from the intervention messages. The measure will be administered at 3, 6, and 12 months and change over time will be assessed. Relatedness is a hypothesized mediator in this study.

   Time frame: up to 12 months

7. Autonomy Support

   Items are adapted from the Health Care Climate Questionnaire, which is a measure of how the participant perceives support from a healthcare provider, to measure autonomy support from the program. The scale includes 15 items rated on a scale of 1 (strongly disagree) to 7 (strongly agree) (e.g., "I feel that \[the program\] has provided me choices and options.") Scores are calculated by averaging the individual item scores (with item 13 reverse-scored). Higher average scores represent a higher level of perceived autonomy support. Autonomy support will be measured at 3, 6, and 12 months. Autonomy Support is a hypothesized mediator in this study.

   Time frame: up to 12 months

8. Autonomous Motivation

   Change in treatment self-regulation from baseline to 3, 6, and 12 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. They are: Autonomous Regulation: 2, 3, 7, 10, 13, 16, 18, 19 Controlled Regulation: 1, 4, 5, 6, 8, 9, 11, 12, 14, 15, 17. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Autonomous Motivation is a hypothesized mediator in this study.

   Time frame: Baseline up to 12 months

Related links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials ↗

Individual participant data

Plan to share: Yes — Any data sharing will be under the auspices of UNC-approved data-sharing agreements with investigators wishing to use the data. Specific requests will provide a limited dataset to prospective investigators after any data-cleaning prior to sharing. Potential investigators will submit a request to the Contact PI (Valle) that includes hypotheses, variables needed, and plans for disseminating findings. Final research data analyzed for publication of main trial findings as specified in our specific aims will be made available no later than acceptance of data for publication. Any publication will be embargoed per the journal's requirements or regulations and will be made publicly available no later than 12 months after the official date of publication in accordance with NIH Public Access Policy. The release of specific data may be delayed if data are part of an analysis being prepared for a separate publication.

Supporting information: Study protocol, Sap, Icf