Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837586
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-03-30
Brief Title:
Self-Weighing for Adolescents Seeking Obesity Treatment
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Self-weighing for Weight Management in Adolescents Seeking Obesity Treatment A Randomized Pilot
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
99 patients age 12 to 18 years old with obesity BMI 95th percentile will be randomized to one of three treatment interventions
1 Usual Care
2 Usual Care plus advice to weigh daily on simple scale
3 Usual Care plus advice to weigh-daily on an EHR-connected scale
Survey data collected at baseline 2 4 6 and 12-weeks and qualitative interviews at 12 weeks will assess acceptability safety self-efficacy and BMI Recruitment will also be assessed eligible patients who consent In order to understand real-world feasibility of this intervention the clinic staff will work with patients to connect the scales to Epic
1 Usual Care
2 Usual Care plus advice to weigh daily on simple scale
3 Usual Care plus advice to weigh-daily on an EHR-connected scale
Survey data collected at baseline 2 4 6 and 12-weeks and qualitative interviews at 12 weeks will assess acceptability safety self-efficacy and BMI Recruitment will also be assessed eligible patients who consent In order to understand real-world feasibility of this intervention the clinic staff will work with patients to connect the scales to Epic
Detailed Description:
Obesity is a major public health issue because of its high prevalence and many health consequences Obesity is driven by a dysregulation of the bodys energy regulatory systems and is life-shortening Obesity during the critical adolescent period increases risk of diabetes cardiometabolic disease all-cause mortality and adulthood obesity Rates of obesity-related cancers are increasing in younger populations In addition to poorer health individuals with obesity during adolescence are at risk for lower productivity income and likelihood of employment in adulthood making obesity treatment and prevention important for reducing disparities Despite consensus on the need for multi-component interventions for obesity rates continue to climb for adolescents youth of low-income backgrounds and youth of racialethnic minority backgrounds Clinicians cite lack of time and tools to help patients lose weight as barriers to weight counseling and thus need practical effective interventions they can feasibly disseminate from a busy clinical setting
Self-weighing grounded in behavior change theory is effective for weight loss in adults Self-monitoring is grounded in Social Cognitive Theory SCT which describes behavior change as happening with reciprocal interactions with ones environment creating external and internal self-reinforcement Self-monitoring is one such interaction that improves self-awareness through proximate self-measurement and improves self-efficacy self-control and self-reinforcement Self-weighing SW is a form of self-monitoring for weight loss that is grounded in SCT Daily SW in adults has been associated with increased exercise and cognitive restraint and reduced snacking television watching and consumption of sweets
The investigator found no data on patient and parent perspectives on connecting scales to the EHR for daily weights in adolescents with obesity seeking obesity treatment
99 patients age 12 to 18 years old with obesity BMI 95th percentile to be randomized to one of three treatment interventions
1 Usual Care
2 Usual Care plus advice to weigh daily on simple scale
3 Usual Care plus advice to weigh-daily on an EHR-connected scale
Survey data collected at baseline 2 4 6 and 12-weeks and qualitative interviews at 12 weeks will assess acceptability safety self-efficacy and BMI Recruitment will also be assessed eligible patients who consent In order to understand real-world feasibility of this intervention the clinic staff will work with patients to connect the scales to Epic
Self-weighing grounded in behavior change theory is effective for weight loss in adults Self-monitoring is grounded in Social Cognitive Theory SCT which describes behavior change as happening with reciprocal interactions with ones environment creating external and internal self-reinforcement Self-monitoring is one such interaction that improves self-awareness through proximate self-measurement and improves self-efficacy self-control and self-reinforcement Self-weighing SW is a form of self-monitoring for weight loss that is grounded in SCT Daily SW in adults has been associated with increased exercise and cognitive restraint and reduced snacking television watching and consumption of sweets
The investigator found no data on patient and parent perspectives on connecting scales to the EHR for daily weights in adolescents with obesity seeking obesity treatment
99 patients age 12 to 18 years old with obesity BMI 95th percentile to be randomized to one of three treatment interventions
1 Usual Care
2 Usual Care plus advice to weigh daily on simple scale
3 Usual Care plus advice to weigh-daily on an EHR-connected scale
Survey data collected at baseline 2 4 6 and 12-weeks and qualitative interviews at 12 weeks will assess acceptability safety self-efficacy and BMI Recruitment will also be assessed eligible patients who consent In order to understand real-world feasibility of this intervention the clinic staff will work with patients to connect the scales to Epic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None