Obesity, ChildhoodDALIANCT06520787

DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions

An observational study of Obesity, Childhood, run by Adhera Health, Inc. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this feasibility study is to explore the needs of families with children with obesity and evaluate the impact of a combined intervention (children with obesity receiving pharmacological therapy in combination with the Adhera Caring Digital Program®) on treatment satisfaction, adherence, and mood. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity, Childhood
What is being tested?: ACDP® and pharmacological treatment for obesity
How many people: 40 participants
Where: 1 siteSpain
Study dates: 11 Mar 2025to 19 May 2026
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: The sample of the study (caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention.

Who may be able to join

Caregivers of children between 13 and 18 years who are diagnosed with obesity and undergoing treatment according to the approved label by AEMPS1 (adolescents with obesity aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex).
Families of children with obesity who have been under pharmacological treatment before screening. This includes treatment with any of the following medications orlistat, metformin, liraglutide, semaglutide.
Participants who are willing to join ACDP® for 10 months and can interact with a smartphone during that time.
The family is willing to complement the pharmacological obesity treatment with a digital intervention.
Participants (patients and their caregivers) must be willing to use wearables for the entire length of the study.
Parents previously using a wearable will agree not to use it during the length of the study, as their wearable account must be synched to the patient's device. Further, they may need to agree on changing the account data for height, weight, and gender in their Google account.

Who cannot join

Families not fluent in Spanish.
Families of children with obesity and comorbidities.
Families of children with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes).

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009

Other trials in Spain

About this study

To evaluate the impact of the treatment combination (ACDP® and pharmacological treatment) in terms of satisfaction, engagement, adherence and mood, in families with children with obesity.
To better understand the educational and support needs of the families of children with obesity while under treatment and lifestyle changes.

Participants will:

Use the Adhera Caring Digital Program® (ACDP®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials.
Take pharmacological treatment as prescribed for one year.
Wear activity wristbands/watches to collect biometric data.
Attend monthly clinic visits for assessments and monitoring.
Complete psychometric questionnaires to measure satisfaction, adherence, and emotional outcomes.
Engage in chat-based communication and video conferencing with health coaches for support and monitoring.

Conditions: Obesity, Childhood
Being tested: ACDP® and pharmacological treatment for obesity
Keywords: Obesity, Digital health, Treatment satisfaction, pharmacological treatment for obesity
Medical subject headings: Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACDP® and pharmacological treatment for obesityCombination product
40 Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention. After the recruitment, the family will join Adhera Caring Digital Program® for 10 months. The combined intervention (digital and pharmacological intervention) will last one year, and there will be a 2-month follow-up. During the whole study (12 months, from recruiting to the end of follow-up) participants will wear a smartwatch (Fitbit or similar).

Study groups in NCT06520787
Study group	Role	What they receive
Cohort		40 families with children already receiving pharmacological therapy as per clinical indication will be asked to use the ACDP® for obesity. We will track their progress with the digital intervention for ten months, and there will be a 2-month follow-up (total 12 months) Receives: Combination Product: ACDP® and pharmacological treatment for obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment satisfaction
Treatment satisfaction measured by Treatment Expectation Scale/Treatment Satisfacyion Scale. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better outcomes (greater treatment expectation/satisfaction).
Measured: Day 1 to Day 365
Treatment adherence 1
Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)
Measured: Day 1 to Day 365
Treatment adherence 2
Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).
Measured: Day 1 to Day 365
Treatment adherence 3
Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.
Measured: Day 150 to Day 365

Secondary outcomes (19)

Emotional outcome 1
These tend to be sensitive to change in short-term and will include distress assessed by the Depression Anxiety and Stress Scale (DASS-21) and the distress thermometer. Minimum Value: 0. Maximum Value: 63. Interpretation: Higher scores indicate worse outcomes (greater levels of depression, anxiety, and stress).
Measured: Baseline (Day 1) to Day 365
Emotional outcome 2
These tend to be sensitive to change in short-term and will include Weight Self-Stigma Questionnaire (S-WSSQ). Minimum Value: 12. Maximum Value: 60. Interpretation: Higher scores indicate worse outcomes (greater self-stigma related to weight).
Measured: Baseline (Day 1) to Day 365
Emotional outcome 3
These tend to be sensitive to change in short-term and will include perceived self-efficacy assessment by the General Self-Efficacy Scale (GSE). Minimum Value: 10. Maximum Value: 40. Interpretation: Higher scores indicate better outcomes (greater self-efficacy).
Measured: Baseline (Day 1) to Day 365
Health-related Quality of Life (HrQoL)
Quality of life tends to change over longer periods of time, and often do require follow-ups of 6 months or one year. However, some dimensions (e.g. mental) are estimated to change faster in shorter periods. HrQoL will be assessed with regard to the children by the caregivers' perspective from the KIDSCREEN-10. Minimum Value: 10. Maximum Value: 50. Interpretation: Higher scores indicate better outcomes (better health-related quality of life).
Measured: Baseline (Day 1) to Day 365
Levels of physical activity
Life-style questionnaires on Levels of physical activity (APALQ; Assessment of Physical Activity Levels Questionnaire ). Minimum Value: Varies based on questionnaire design. Maximum Value: Varies based on questionnaire design. Interpretation: Higher scores generally indicate better outcomes (higher levels of physical activity).
Measured: Baseline (Day 1) to Day 365
Height
From bioimpedance scale. Standard medical measurement. Unit of measure: meters.
Measured: Baseline (Day 1) to Day 365
Weight
From bioimpedance scale. Standard medical measurement. Unit of measure: kilograms.
Measured: Baseline (Day 1) to Day 365
Body Mass Index (BMI)
From bioimpedance scale. Calculated from height and weight. Unit of measure: kg/m²
Measured: Baseline (Day 1) to Day 365
Blood pressure
Standard pressure measurement. Unit of measure: mmHg.
Measured: Baseline (Day 1) to Day 365
Time since diagnosis
From patient medical records or self-reported data. Unit of measure: weeks, months or years.
Measured: Baseline (Day 1) to Day 365
Previous obesity treatments
From patient medical records and self-reported data. Unit of measure: Description of treatment (qualitative data).
Measured: Baseline (Day 1) to Day 365
Cholesterol levels
Blood test results. Unit of measure: mg/dL
Measured: Baseline (Day 1) to Day 365
Complications
From patient medical records or self-reported. Unit of measure: Incidence and type of complications (qualitative data)
Measured: Baseline (Day 1) to Day 365
Step count
From wearable device. Unit of measure: number of steps per day.
Measured: Baseline (Day 1) to Day 396
Physical activity levels
From wearable device. Unit of measure: minutes of moderate to vigorous activity per day.
Measured: Baseline (Day 1) to Day 300
Sleep quality
From wearable device. Unit of measure: Sleep score or duration and quality of sleep (hours and sleep stages).
Measured: Baseline (Day 1) to Day 300
Heart rate
From wearable device. Unit of measure: average resting heart rate (beats per minute).
Measured: Baseline (Day 1) to Day 300
6-minute walk test performance
Standardized 6-minute walk test. Unit of measure: distance covered in meters.
Measured: Baseline (Day 1) to Day 365
System Usability
Measures the perceived usability of ACDP. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better perceibed usability
Measured: Day 150 to 300

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202519 May 2026

First posted25 Jul 2024
Study start11 Mar 2025
Primary completion19 Mar 2026
Study completion19 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT06520787
Sponsor's protocol ID: DAL-CLI-24-001
Acronym: DALIA
Status last verified: May 2026
First submitted: 4 Jul 2024
Last updated: 22 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
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All Obesity, Childhood trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DAta-driven personaLIzation of a digitAl Health Solution to Support Family Caregivers of Children With Chronic Conditions
ClinicalTrials.gov ID: NCT06520787
Acronym / sponsor ID: DALIA / DAL-CLI-24-001
Conditions: Obesity, Childhood
Keywords: Obesity, Digital health, Treatment satisfaction, pharmacological treatment for obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Adhera Health, Inc.Industry (pharma, biotech, devices)
Collaborators: Hospital Universitario Miguel Servet, Zaragoza, University of Valencia, University of Seville
Study start: 11 Mar 2025 (actual)
Primary completion: 19 Mar 2026 (actual)
Study completion: 19 May 2026 (actual)
First posted: 25 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the impact of the treatment combination (ACDP® and pharmacological treatment) in terms of satisfaction, engagement, adherence and mood, in families with children with obesity.
To better understand the educational and support needs of the families of children with obesity while under treatment and lifestyle changes.

Participants will:

Use the Adhera Caring Digital Program® (ACDP®) for obesity, which includes digital therapeutic software, personalized messages, and educational materials.
Take pharmacological treatment as prescribed for one year.
Wear activity wristbands/watches to collect biometric data.
Attend monthly clinic visits for assessments and monitoring.
Complete psychometric questionnaires to measure satisfaction, adherence, and emotional outcomes.
Engage in chat-based communication and video conferencing with health coaches for support and monitoring.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Cohort	–	Combination Product: ACDP® and pharmacological treatment for obesity40 families with children already receiving pharmacological therapy as per clinical indication will be asked to use the ACDP® for obesity. We will track their progress with the digital intervention for ten months, and there will be a 2-month follow-up (total 12 months)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The sample of the study (caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric health attention to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants. Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention.

Key inclusion criteria (6 listed)

Caregivers of children between 13 and 18 years who are diagnosed with obesity and undergoing treatment according to the approved label by AEMPS1 (adolescents with obesity aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex).
Families of children with obesity who have been under pharmacological treatment before screening. This includes treatment with any of the following medications orlistat, metformin, liraglutide, semaglutide.
Participants who are willing to join ACDP® for 10 months and can interact with a smartphone during that time.
The family is willing to complement the pharmacological obesity treatment with a digital intervention.
Participants (patients and their caregivers) must be willing to use wearables for the entire length of the study.

Key exclusion criteria (3 listed)

Families not fluent in Spanish.
Families of children with obesity and comorbidities.
Families of children with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACDP® and pharmacological treatment for obesity40 Families of children with obesity that are already undergoing treatment and are willing to join a combined intervention. After the recruitment, the family will join Adhera Caring Digital Program® for 10 months. The combined intervention (digital and pharmacological intervention) will last one year, and there will be a 2-month follow-up. During the whole study (12 months, from recruiting to the end of follow-up) participants will wear a smartwatch (Fitbit or similar).	Combination product	Cohort

Primary outcome

Treatment satisfaction
Time frame: Day 1 to Day 365
Treatment satisfaction measured by Treatment Expectation Scale/Treatment Satisfacyion Scale. Minimum Value: 0. Maximum Value: 10. Interpretation: Higher scores indicate better outcomes (greater treatment expectation/satisfaction).
Treatment adherence 1
Time frame: Day 1 to Day 365
Treatment adherence measured by injection (self-reported). Unit of measure: Number of injections (quantitative data)
Treatment adherence 2
Time frame: Day 1 to Day 365
Treatment adherence measured by changes in nutritional compliance (self-reported). Unit of measure: Description of diet (qualitative data).
Treatment adherence 3
Time frame: Day 150 to Day 365
Treatment adherence measured by discontinuation (and reasons behind it). Unit of measure: Incidence of discontinuation with categorized reasons.

19 secondary outcomes

Emotional outcome 1
Time frame: Baseline (Day 1) to Day 365
Emotional outcome 2
Time frame: Baseline (Day 1) to Day 365
Emotional outcome 3
Time frame: Baseline (Day 1) to Day 365
Health-related Quality of Life (HrQoL)
Time frame: Baseline (Day 1) to Day 365
Levels of physical activity
Time frame: Baseline (Day 1) to Day 365
Height
Time frame: Baseline (Day 1) to Day 365
Weight
Time frame: Baseline (Day 1) to Day 365
Body Mass Index (BMI)
Time frame: Baseline (Day 1) to Day 365
Blood pressure
Time frame: Baseline (Day 1) to Day 365
Time since diagnosis
Time frame: Baseline (Day 1) to Day 365
Previous obesity treatments
Time frame: Baseline (Day 1) to Day 365
Cholesterol levels
Time frame: Baseline (Day 1) to Day 365
Complications
Time frame: Baseline (Day 1) to Day 365
Step count
Time frame: Baseline (Day 1) to Day 396
Physical activity levels
Time frame: Baseline (Day 1) to Day 300
Sleep quality
Time frame: Baseline (Day 1) to Day 300
Heart rate
Time frame: Baseline (Day 1) to Day 300
6-minute walk test performance
Time frame: Baseline (Day 1) to Day 365
System Usability
Time frame: Day 150 to 300

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Individual participant dataSharing planned: No

Related trials for Obesity, Childhood

Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood, run by Adhera Health, Inc. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment satisfaction (time frame: Day 1 to Day 365). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06520787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.