Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335810
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-22
Brief Title:
Reducing Obesity Using Social Ties Program
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Reducing Obesity Using Social Ties ROBUST Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ROBUST
Brief Summary:
This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change Specifically the study will test if by including up to two friends family members or co-workers in a lifestyle intervention for weight loss the person enrolled in the study loses more weight than someone whose friends family members or co-workers were not invited to participate
Detailed Description:
The investigators will evaluate whether the ROBUST intervention not only addresses individual-level behaviors ie healthy eating increased physical activity but also
1 reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking communicating and acting as if a health risk ie Type 2 diabetes is shared and
2 dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset
Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention
Participants will
1 Be randomly assigned to either the study group which is asked to invite up to two friends or family members to join them at three coaching sessions or the group that does not invite anyone
2 Receive 15 coaching sessions over 24 weeks
3 Complete an online questionnaire about eating and physical activity habits confidence in developing healthier habits mood and health habits of twelve of their closest friends and family members
4 Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily
5 The invited friends and family members will also be asked to complete a brief questionnaire about their eating and physical activity habits when they start and end the study
1 reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking communicating and acting as if a health risk ie Type 2 diabetes is shared and
2 dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset
Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention
Participants will
1 Be randomly assigned to either the study group which is asked to invite up to two friends or family members to join them at three coaching sessions or the group that does not invite anyone
2 Receive 15 coaching sessions over 24 weeks
3 Complete an online questionnaire about eating and physical activity habits confidence in developing healthier habits mood and health habits of twelve of their closest friends and family members
4 Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily
5 The invited friends and family members will also be asked to complete a brief questionnaire about their eating and physical activity habits when they start and end the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK135949-01 | NIH | None | httpsreporternihgovquickSearchR01DK135949-01 |