Emotional EatingNCT06081023
Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
A study testing Psycho-educational weight reduction program in people with Emotional Eating and Obesity, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial summary
The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Eating, Obesity
- What is being tested?
- Psycho-educational weight reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2022to 29 Jul 2022
- Phase
- Interventional
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals must be enrolled at a university.
- Based on World Health Organizations age range young adults were selected for the current study i-e 19 years to 35 years (WHO; 2019).
Who cannot join
- The young adults who diagnosed with any chronic health concern, either psychological or physical must not be included in the current study.
- The individuals who joined any kind of weight loss program or gym were also not included in the study.
- Individuals older than 35 were not included in the current study either.
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity
Read the detailed description
All participants who provide written informed consent will go through a screening process to evaluate their eligibility for study entrance after being briefed about the study and any potential risks. Individuals who met the eligibility requirements will then be randomly assigned to the control group and the experimental group.
- Conditions
- Emotional Eating, Obesity
- Being tested
- Psycho-educational weight reduction program
- Keywords
- Psycho-educational weight reduction program
- Medical subject headings
- Emotional Eating, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational weight reduction programBehavioural
This program provides behavioral technique in order to minimize level of emotional eating and level of obesity
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | No intervention | This arm was provided with only a relaxing behavioral technique |
| Psycho-educational weight reduction program | Experimental | This arm was provided with treatment of reducing emotional eating and obesity level Receives: Behavioral: Psycho-educational weight reduction program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Emotional Eating on Emotional Eating Scale (EES-25) after 12 weeks
The EES-25 is a validated self-report scale assessing the level of emotional eating. Possible scores range from 25 (No desire to eat) to 125 (an overwhelming urge to eat) Change=week 12 score-baseline score
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start5 Mar 2022
- Primary completion29 Apr 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional EatingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two groups i-e control and experimental. The experimental group was provided with treatment while the control group was only provided with behavioral relaxing techniques.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081023
- Sponsor's protocol ID
- 2020(fall).MPhil(Psy)-009
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the obtained information will be shared maintaining confidentiality and anonymity of obtained data
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
- ClinicalTrials.gov ID
- NCT06081023
- Acronym / sponsor ID
- 2020(fall).MPhil(Psy)-009
- Conditions
- Emotional Eating, Obesity
- Keywords
- Psycho-educational weight reduction program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 5 Mar 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 12 Oct 2023 (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.
The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity
Detailed description
All participants who provide written informed consent will go through a screening process to evaluate their eligibility for study entrance after being briefed about the study and any potential risks. Individuals who met the eligibility requirements will then be randomly assigned to the control group and the experimental group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups i-e control and experimental. The experimental group was provided with treatment while the control group was only provided with behavioral relaxing techniques.
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | No intervention | –This arm was provided with only a relaxing behavioral technique |
| Psycho-educational weight reduction program | Experimental | Behavioral: Psycho-educational weight reduction programThis arm was provided with treatment of reducing emotional eating and obesity level |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals must be enrolled at a university.
- Based on World Health Organizations age range young adults were selected for the current study i-e 19 years to 35 years (WHO; 2019).
Key exclusion criteria (3 listed)
- The young adults who diagnosed with any chronic health concern, either psychological or physical must not be included in the current study.
- The individuals who joined any kind of weight loss program or gym were also not included in the study.
- Individuals older than 35 were not included in the current study either.
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 |
|---|---|---|
| Psycho-educational weight reduction programThis program provides behavioral technique in order to minimize level of emotional eating and level of obesity | Behavioural | Psycho-educational weight reduction program |
Primary outcome
Change from Baseline in Emotional Eating on Emotional Eating Scale (EES-25) after 12 weeks
Time frame: Baseline and Week 12
The EES-25 is a validated self-report scale assessing the level of emotional eating. Possible scores range from 25 (No desire to eat) to 125 (an overwhelming urge to eat) Change=week 12 score-baseline score
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 12 Oct 2023.
- Individual participant dataSharing planned: Yes. All the obtained information will be shared maintaining confidentiality and anonymity of obtained data
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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?
A study testing Psycho-educational weight reduction program in people with Emotional Eating and Obesity, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
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 2 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 12 Oct 2023. 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 Pakistan. 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?
Change from Baseline in Emotional Eating on Emotional Eating Scale (EES-25) after 12 weeks (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.