- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081023
Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults
October 10, 2023 updated by: Health Education Research Foundation (HERF)
The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Nimra Anjum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Progressive Muscle Relaxation
This arm was provided with only a relaxing behavioral technique
|
|
|
Experimental: Psycho-educational weight reduction program
This arm was provided with treatment of reducing emotional eating and obesity level
|
This program provides behavioral technique in order to minimize level of emotional eating and level of obesity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2022
Primary Completion (Actual)
April 29, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
October 10, 2023
First Posted (Actual)
October 12, 2023
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020(fall).MPhil(Psy)-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All the obtained information will be shared maintaining confidentiality and anonymity of obtained data
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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