Mobile Weight Loss Intervention for Adolescent and Young Adult Cancer Survivors

NCT06171945 | Completed DMC

• 1 other identifier: LCCC2133
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a 6-month pilot randomized trial to determine the feasibility and acceptability of theory-based mobile weight loss interventions for survivors of adolescent and young adult cancer (AYAs). The interventions use a mobile smartphone application, previously developed for individuals at risk for type 2 diabetes and adapted for AYAs, that integrates weight and physical activity from digital devices with simplified dietary monitoring in a behavioral weight loss program.

Conditions

Cancer; Physical Activity; Cancer Survivorship; Mental Health; Obesity

Keywords

adolescent; young adult; mobile application; physical activity; nutrition; overweight; positive psychology; digital intervention; diet; weight loss; weight management; bladder cancer; bone cancer; brain cancer; breast cancer; cervical cancer; colon cancer; endometrial cancer; head and neck cancer; leukemia; liver cancer; lymphoma (Hodgkin's); lymphoma (Non-Hodgkin's); melanoma; oral cancer; pancreatic cancer; pharyngeal cancer; rectal cancer; renal cancer; sarcoma; testicular cancer; thyroid cancer

Outcome Measures

Primary Outcomes (3)

• Feasibility of interventions as measured by accrual rate

  Feasibility of interventions as measured by accrual rate will be calculated as the number of adolescent and young adult cancer (AYA) survivors who agreed to participate divided by the number of months of recruitment

  at 3 months

• Feasibility of interventions as measured by participation rate

  Feasibility of interventions as measured by participation rate will be calculated as the number of participants who agreed to participate divided by the number of eligible AYA survivors.

  at 3 months

• Feasibility of interventions as measured by retention rate

  Feasibility of interventions as measured by retention rate will be calculated as the number of AYA survivor participants who completed 3-month measures divided by the number who participated.

  At 3 months

Secondary Outcomes (20)

• Retention rate at 6 months

  At 6 months

• Acceptability of Young Adult Cancers (AYAs) Connect

  At 3 and 6 month

• Adherence to dietary tracking

  Up to 6 month

• Adherence to physical activity monitoring

  Up to 6 month

• Adherence to self-weighing

  Up to 6 month

Study Arms (3)

AYA Connect

EXPERIMENTAL

Adolescent and young adult cancer survivors receive AYA Connect intervention.

Behavioral: AYA Connect intervention

AYA Connect-PP

EXPERIMENTAL

Adolescent and young adult cancer survivors receive AYA Connect-PP intervention.

Behavioral: AYA Connect intervention; Behavioral: Positive Psychology (PP) intervention

AYA Connect-PP+

EXPERIMENTAL

Adolescent and young adult cancer survivors receive AYA Connect-PP+ intervention.

Behavioral: AYA Connect intervention; Behavioral: Positive Psychology (PP) intervention; Behavioral: Positive Psychology Plus (PP+) intervention

Interventions

AYA Connect intervention BEHAVIORAL

Participants will receive a smart scale, activity tracker, an individual kickoff videochat session with a health coach, and access to a mobile smartphone app that includes weekly behavioral lessons, dietary tracking log, daily weight-related behavioral goals, tailored feedback summaries, and in-app health-related messages.

AYA Connect; AYA Connect-PP; AYA Connect-PP+

Positive Psychology (PP) intervention BEHAVIORAL

Participants will receive lessons about positive psychology (PP) strategies, weekly goals for PP exercises, and in-app health-related messages that include reminders to practice PP exercises.

AYA Connect-PP; AYA Connect-PP+

Positive Psychology Plus (PP+) intervention BEHAVIORAL

Participants will receive weekly individual videochat sessions with a health coach.

AYA Connect-PP+

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Currently age 18-39
• Diagnosed with first invasive cancer between the ages of 15-39 years old
• Within 10 years of diagnosis with no evidence of progressive disease or second primary cancers
• Completed active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy, and/or definitive surgical intervention) at least six months prior to enrollment, except maybe receiving "maintenance" therapy to prevent recurrences
• Body Mass Index (BMI) of 25-50 kg/m2

You may not qualify if:

• Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
• Report a history of heart attack or stroke within the previous 6 months
• Health problems that preclude the ability to walk for physical activity
• Lost 5% or more of body weight (and kept it off) in the last 3 months
• Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa) or any compensatory behaviors within the previous 3 months
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
• Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
• Hospitalization for depression or other psychiatric disorder within the past 12 months
• History of psychotic disorder or bipolar disorder
• Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
• Currently using prescription medications with known effects on appetite or weight.
• Previous surgical procedure for weight loss or planned weight loss surgery in the next 6 months
• Inability to speak and read English
• Do not have an iPhone with active data and text messaging plan
• No Internet access

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Neoplasms; Motor Activity; Psychological Well-Being; Obesity; Overweight; Weight Loss; Urinary Bladder Neoplasms; Bone Neoplasms; Brain Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Colonic Neoplasms; Endometrial Neoplasms; Head and Neck Neoplasms; Leukemia; Liver Neoplasms; Hodgkin Disease; Lymphoma, Non-Hodgkin; Melanoma; Mouth Neoplasms; Pancreatic Neoplasms; Pharyngeal Neoplasms; Rectal Neoplasms; Kidney Neoplasms; Sarcoma; Testicular Neoplasms; Thyroid Neoplasms

Interventions

Psychology, Positive; Methods

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Mouth Diseases; Stomatognathic Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Rectal Diseases; Kidney Diseases; Neoplasms, Connective and Soft Tissue; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Gonadal Disorders; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Investigative Techniques

Study Officials

• Carmina Valle, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 15, 2023
• Study Start: March 1, 2024
• Primary Completion: July 13, 2025
• Study Completion: October 5, 2025
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)