Trial Outcomes & Findings for Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese (NCT NCT01452269)

Last Updated: 2023-09-06

Results Overview

We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.

Recruitment status

COMPLETED

Study phase

Target enrollment

104 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2023-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Intervention Group This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Delayed Intervention Group This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.
Overall Study STARTED	48	56
Overall Study COMPLETED	47	51
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of a Healthy Lifestyle Intervention for Deaf Adults Who Are Overweight or Obese

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Intervention Group n=48 Participants This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Delayed Intervention Group n=56 Participants This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=99 Participants	53 Participants n=107 Participants	97 Participants n=206 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Age, Continuous	53.6 years STANDARD_DEVIATION 7.4 • n=99 Participants	53.4 years STANDARD_DEVIATION 7.8 • n=107 Participants	53.5 years STANDARD_DEVIATION 7.6 • n=206 Participants
Sex: Female, Male Female	32 Participants n=99 Participants	39 Participants n=107 Participants	71 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	17 Participants n=107 Participants	33 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=99 Participants	54 Participants n=107 Participants	99 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	45 Participants n=99 Participants	50 Participants n=107 Participants	95 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	48 participants n=99 Participants	56 participants n=107 Participants	104 participants n=206 Participants
Became Deaf age 3 or younger Became Deaf age 3 or younger	42 participants n=99 Participants	44 participants n=107 Participants	86 participants n=206 Participants
Became Deaf age 3 or younger Became Deaf age 4 or older, or unknown age	6 participants n=99 Participants	12 participants n=107 Participants	18 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=48 Participants This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Delayed Intervention Group n=56 Participants This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.
Weight Change	-5.33 kilograms Standard Error 0.88	-1.98 kilograms Standard Error 0.60

PRIMARY outcome

Timeframe: Baseline and 6 months

We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=48 Participants This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Delayed Intervention Group n=56 Participants This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.
Change in Dietary Risk Assessment (DRA) Score	-6.3 DRA score Standard Error 1.2	-3.7 DRA score Standard Error 1.3

PRIMARY outcome

Timeframe: Baseline and 6 months

We measured the mean change in the moderate PAA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).

Outcome measures

Outcome measures
Measure	Immediate Intervention Group n=48 Participants This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.	Delayed Intervention Group n=56 Participants This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions. Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles). The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program.
Change in Physical Activity Assessment (PAA) Score	1.6 moderate PAA score Standard Error 0.5	1.0 moderate PAA score Standard Error 0.5

Adverse Events

Immediate Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven Barnett

University of Rochester

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place