Weight Loss Maintenance
Conditions
Brief summary
The intervention being studied is a 12-week nutrition and physical activity intervention, delivered using videoconference technology by registered dietitian clinicians to maintain weight loss and functional gains in older adults who successfully completed a weight loss intervention. The Legacy Intervention will include cognitive behavioral strategies (e.g., goal setting, self-monitoring, and social support), and draw upon a toolbox of e-approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual and group nutrition classes, and step tracking device.
Interventions
BEHAVIORALLegacy Intervention
The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participated in a weight loss intervention in the last 9 months and lost ≥ 3% body weight and improved SPPB score by ≥ 1 point or 6MWT by ≥ 50 meters * Age ≥ 60 * Able to speak and understand spoken and written English. * Able to record dietary intake and weight
Exclusion criteria
* Presence of unstable or symptomatic life-threatening illness * Neurological conditions causing functional impairment, including Parkinson's disease, multiple sclerosis, and permanent disability due to stroke * Inability to complete physical function assessment * No access to internet connection to participate in the tele-intervention * Unable or unwilling to use provided tablet to participant in tele-intervention * History of cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Retention | 12 week endpoint | Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants |
| Acceptability as Measured by Participant Satisfaction | 12 week endpoint | Participants will asked to rate their satisfaction by answering the question Overall, I'm glad I participated in this weight maintenance program with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight as Measured by the Aria Fitbit Scale | 0 weeks, 12 weeks | Body weight in pounds. |
| Change in Average Weekly Steps Measured Using Garmin Watch | 0 weeks, 12 weeks | Average step counts using Garmin watch. |
| Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) | 0 weeks,12 weeks | Average total calories consumed. |
| Change in Stress Using the Perceived Stress Scale | 0 weeks, 12 weeks | Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. |
| Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | 0 weeks, 12 weeks | Score ranges from 0-60 with higher scores indicating greater depression symptoms. |
| Change in Mood Using the Profile of Mood States Questionnaire | 0 weeks, 12 weeks | Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from not at all to extremely. |
| Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale | 0 weeks, 12 weeks | Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning. |
| Change in Physical Performance as Measured by the Short Physical Performance Battery | 0 weeks, 12 weeks | Scores range from 0 to 12 with higher score indicating better performance. |
| Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale | 0 weeks, 12 weeks | Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health |
| Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale | 0 weeks, 12 weeks | Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue |
| Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale | 0 weeks, 12 weeks | Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being |
| Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale | 0 weeks, 12 weeks | Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning. |
| Quality of Life Using the SF-36 Questionnaire - Pain Scale | 0 weeks, 12 weeks | Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain. |
| Quality of Life Using the SF-36 Questionnaire - General Health Scale | 0 weeks, 12 weeks | General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health |
| Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale | 0 weeks, 12 weeks | Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health |
| Change in Physical Function as Measured Using the 6 Minute Walk Test | 0 weeks, 12 weeks | Change in distance walked in six minutes from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Legacy Intervention Older adults who have successfully completed a lifestyle intervention (lost at least 3% body weight and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) will be enrolled in a tele-nutrition and tele-exercise intervention.
Legacy Intervention: The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Legacy Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Acceptability as Measured by Participant Satisfaction
Participants will asked to rate their satisfaction by answering the question Overall, I'm glad I participated in this weight maintenance program with the following possible responses: 1- strongly disagree , 2- disagree, 3 - neither agree nor disagree, 4- agree, and and 5 -strongly agree. Score ranges from 1- 5 with higher score indicating greater satisfaction
Time frame: 12 week endpoint
Population: Participants who completed the study; data were not collected for one participant who completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Legacy Intervention | Acceptability as Measured by Participant Satisfaction | 4.8 score on a scale | Standard Deviation 0.4 |
Primary
Proportion Retention
Proportion retention will be computed by dividing the number of retained subjects at the end of the intervention by the total number of participants
Time frame: 12 week endpoint
Population: Participants who completed the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Legacy Intervention | Proportion Retention | 93 percent of participants |
Secondary
Change in Average Weekly Steps Measured Using Garmin Watch
Average step counts using Garmin watch.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study; data were not collected for one participant who completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Average Weekly Steps Measured Using Garmin Watch | 0 weeks (baseline) | 6204.8 steps per week | Standard Deviation 3802.1 |
| Legacy Intervention | Change in Average Weekly Steps Measured Using Garmin Watch | 12 weeks | 6365.0 steps per week | Standard Deviation 4109.8 |
Secondary
Change in Body Weight as Measured by the Aria Fitbit Scale
Body weight in pounds.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study; data were not collected for one participant who completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Body Weight as Measured by the Aria Fitbit Scale | 0 weeks (baseline) | 216.1 pounds | Standard Deviation 29.1 |
| Legacy Intervention | Change in Body Weight as Measured by the Aria Fitbit Scale | 12 weeks | 215.4 pounds | Standard Deviation 27.3 |
Secondary
Change in Mood Using the Profile of Mood States Questionnaire
Change in mood from baseline, 6 and 12 weeks. Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from not at all to extremely.
Time frame: 0 weeks, 12 weeks
Population: To reduce participant burden during the COVID pandemic, this questionnaire was not administered to participants at all, so data from the Profile of Mood States (POMS) Questionnaire were not collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in Mood Using the Profile of Mood States Questionnaire | 0 weeks (baseline) | — |
| Unknown | Change in Mood Using the Profile of Mood States Questionnaire | 12 weeks | — |
Secondary
Change in Physical Function as Measured Using the 6 Minute Walk Test
Change in distance walked in six minutes from baseline
Time frame: 0 weeks, 12 weeks
Population: Due to safety concerns during the COVID pandemic, the 6 Minute Walk Test was not administered to participants at all, so data from the 6 Minute Walk Test were not collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in Physical Function as Measured Using the 6 Minute Walk Test | 0 weeks (baseline) | — |
| Unknown | Change in Physical Function as Measured Using the 6 Minute Walk Test | 12 weeks | — |
Secondary
Change in Physical Performance as Measured by the Short Physical Performance Battery
Scores range from 0 to 12 with higher score indicating better performance.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study; data were not collected for one participant who completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Physical Performance as Measured by the Short Physical Performance Battery | 0 weeks (baseline) | 10.6 score on a scale | Standard Deviation 1.2 |
| Legacy Intervention | Change in Physical Performance as Measured by the Short Physical Performance Battery | 12 weeks | 11.1 score on a scale | Standard Deviation 0.9 |
Secondary
Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)
Score ranges from 0-60 with higher scores indicating greater depression symptoms.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | week 0 (baseline) | 11.3 score on a scale | Standard Deviation 6.8 |
| Legacy Intervention | Change in Self-reported Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D) | week 12 | 8.8 score on a scale | Standard Deviation 7 |
Secondary
Change in Stress Using the Perceived Stress Scale
Perceived Stress Scale is a 10-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Stress Using the Perceived Stress Scale | 0 weeks (baseline) | 10.8 score on a scale | Standard Deviation 5.2 |
| Legacy Intervention | Change in Stress Using the Perceived Stress Scale | 12 weeks | 9.0 score on a scale | Standard Deviation 4.3 |
Secondary
Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days)
Average total calories consumed.
Time frame: 0 weeks,12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) | Baseline | 1418.4 calories | Standard Deviation 364.7 |
| Legacy Intervention | Change in Total Calories Using 3-day Food Record (Participants Record Everything They Eat and Drink for Three Days) | 12 weeks | 1525.8 calories | Standard Deviation 525.3 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale
Emotional Well-Being scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater emotional well-being
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale | 0 weeks (baseline) | 78.1 scores on a scale | Standard Deviation 13.6 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Emotional Well-Being Scale | 12 weeks | 80.9 scores on a scale | Standard Deviation 10.6 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale
Energy/fatigue scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less energy/fatigue
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale | 0 weeks (baseline) | 55.4 scores on a scale | Standard Deviation 21.6 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Energy/Fatigue Scale | 12 weeks | 58.1 scores on a scale | Standard Deviation 20.5 |
Secondary
Quality of Life Using the SF-36 Questionnaire - General Health Scale
General Health scale of the SF-36 is a 5-items scale with a scores ranging from 0-100% where the higher score indicates greater general health
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - General Health Scale | 0 weeks (baseline) | 64.6 scores on a scale | Standard Deviation 15.5 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - General Health Scale | 12 weeks | 63.5 scores on a scale | Standard Deviation 18 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Pain Scale
Pain scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates less pain.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Pain Scale | 0 weeks (baseline) | 68.5 scores on a scale | Standard Deviation 22.9 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Pain Scale | 12 weeks | 75.2 scores on a scale | Standard Deviation 22.4 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale
Role limitations due to emotional problems scale of the SF-36 is a 3-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to emotional health
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale | 0 weeks (baseline) | 66.7 scores on a scale | Standard Deviation 43 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Emotional Problems Scale | 12 weeks | 64.1 scores on a scale | Standard Deviation 46.1 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale
Role limitations due to physical health scale of the SF-36 is a 4-items scale with a scores ranging from 0-100% where the higher score indicates less limitations due to physical health
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale | 0 weeks (baseline) | 59.6 scores on a scale | Standard Deviation 43.9 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Role Limitations Due to Physical Health Scale | 12 weeks | 75.0 scores on a scale | Standard Deviation 39.5 |
Secondary
Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale
Physical functioning scale of the SF-36 is a 10-items scale with a scores ranging from 0-100% where the higher score indicates greater physical functioning.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale | 0 weeks (baseline) | 75.0 scores on a scale | Standard Deviation 18.7 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - SF-36 Physical Functioning Scale | 12 weeks | 79.2 scores on a scale | Standard Deviation 20.6 |
Secondary
Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale
Social Functioning scale of the SF-36 is a 2-items scale with a scores ranging from 0-100% where the higher score indicates greater social functioning.
Time frame: 0 weeks, 12 weeks
Population: Participants who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale | 0 weeks (baseline) | 82.7 scores on a scale | Standard Deviation 25.3 |
| Legacy Intervention | Quality of Life Using the SF-36 Questionnaire - Social Functioning Scale | 12 weeks | 83.7 scores on a scale | Standard Deviation 28.1 |