Tokyo, Dec. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059930) titled 'Implementation research of an intervention for mothers to improve obesity in adults with severe intellectual disabilities' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - NIHON FUKUSHI UNIVERSITY

Condition: Condition - Intellectual disability Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to verify the weight loss effects of a weight loss program developed by the researchers and confirmed to be effective by nurses and other professionals at facilities for people with intellectual disabilities in Aichi Prefecture, and to clarify the challenges in implementing the program nationwide at day care facilities. The study will also propose improvements to address these challenges. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Nurses or other healthcare professionals will intervene with mothers of individuals with severe intellectual disabilities following the program checklist and text. The intervention period is 7.5 months and will be conducted according to the following schedule: Research Session 1, weight measurement one week later, Research Session 2 two weeks later as the baseline, monthly interviews over four months, and a three-month follow-up period after the intervention. First, nurses or other healthcare professionals conduct two 90-minute training sessions using text and explanatory videos on the process of accepting obesity in mothers and behavioral analysis to help mothers decide on target foods that will not cause conflict with their children. Following this, mothers will implement changes to the target foods they decided on at home, record their children's reactions, the amount of target foods consumed, and their weight. Nurses or other staff will conduct 30-minute interviews monthly over the 4-month period, praising mothers' efforts, comparing them to weight loss predictions, and providing support to overcome obstacles. During the month between interviews, nurses or other staff will provide support to mothers via phone twice. Three months after the intervention ends, a follow-up interview is conducted to praise the achievements made, compare them with weight loss predictions, provide support to overcome obstacles, and confirm future goals.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Certification of severe ID (holds an A-level ID certificate in Japan), BMI of 25 or higher, residing with family at home, and Mother's age 75 years or younger. Key exclusion criteria - Receiving dietary guidance from experts within the last 6 months and those deemed inappropriate for participating in the study by facility staff. Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 04 Month 07 Day Date of IRB - 2025 Year 04 Month 22 Day Anticipated trial start date - 2025 Year 06 Month 30 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066042

Disclaimer: Curated by HT Syndication.