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Coaching Veterans to Healthy Weights and Wellness

ASPIRE: Coaching Veterans to Healthy Weights and Wellness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00967668
Acronym
ASPIRE
Enrollment
481
Registered
2009-08-28
Start date
2010-01-31
Completion date
2013-12-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Counseling, Veterans, Weight loss, Physical activity, Diet

Brief summary

ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss (Aspiring to Lifelong Health in VA, aka ASPIRE-VA). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a small steps approach; 2) a simplified Stoplight diet; and 3) user-friendly enhanced pedometers to help participants monitor their physical activity.

Detailed description

Background: Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations. Objectives: To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13. Methods: A three-arm, 12-month randomized pragmatic effectiveness trial was conducted. Participants were recruited from MOVE! referrals and randomly assigned to one of three programs: the 12-month ASPIRE weight loss program delivered 1) individually over the phone (ASPIRE-Phone) or 2) in-person group sessions (ASPIRE-Group); compared to 3) Veteran Health Administration's VHA standard weight loss program, MOVE!. Participants in the ASPIRE arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The ASPIRE program had distinct characteristics: 1) the opportunity for most participants to work with one lifestyle coach throughout treatment, 2) an emphasis on behavior change through a small steps approach; 3) the prominence of self-monitoring both physical activity and food intake as a weight loss tool; and 4) the addition of a purely phone based option. Assessments that included the collection of weight, waist circumference and lab values, along with questionnaires, were conducted at baseline, 3-months and 12-months. ASPIRE also added a follow-up component to the study, which was offered to patients at their 12-month assessment. For phone and group patients, it consisted of sessions every other month and an assessment at 18 and 24 months. Usual care patients participated in the assessments only. Phone-based Interviews were conducted shortly after the 3-month assessment with 19 patients in the ASPIRE phone arm and with 16 in the ASPIRE group arm. These interviews were recorded, transcribed and analyzed using NVivo qualitative software to identify themes associated with successful weight loss at 3-month. Approximately 5% of all phone and group intervention sessions were audio-recorded. An expert rater used a checklist to rate session fidelity. A second rater independently assessed 30% of the recorded sessions to establish inter-rater reliability. The checklist was psychometrically validated. It was hypothesized that greater adherence to core behavioral change processes and patient-centered communication strategies by the interventionists would be associated with higher levels of weight loss. Using intention-to-treat principles guide all analyses. The primary outcome was weight change and secondary outcomes included changes in anthropometric (e.g., waist circumference), behavioral, fitness, psychosocial, and physiological measures. The primary analytic approach relied on a linear mixed-effects model with baseline, 3- and 12-month outcomes (e.g., weight) as dependent variables, with each subject as a random intercept to adjust for within-patient correlation of the repeated measures, fixed predictors of study arm indicators, 3- and 12-month time indicators, and time-by-study arm interactions. Status: All coaching and assessments are complete. A design and rationale paper has been published, a paper highlighting 12-month results is in revision. Papers on fidelity, qualitative findings, the role of mental illness and binge eating on weight loss are in progress. Analyses of 24-month data are underway.

Interventions

BEHAVIORALSmall change approach to improve physical activity and diet

The Aspire to Lifelong Health (ASPIRE) initial treatment program draws on the strengths of traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week in the program, participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle.

BEHAVIORALMOVE! Usual Care

The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Current patient at Ann Arbor or Cleveland medical center. * Current provider- or self-referral to MOVE! program and eligible to participate in MOVE! * 18 years of age and older * Able to communicate in English * Report being able to walk 10 minutes continuously without sitting down to rest * Competent to provide written informed consent

Exclusion criteria

* Enrolled in another research study involving weight loss, nutrition, or physical activity * Being treated for weight loss or on weight loss medications (OTC or prescribed) * Are currently pregnant

Design outcomes

Primary

MeasureTime frameDescription
Change in Weight12 months after enrollmentExpected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data

Secondary

MeasureTime frameDescription
Change in Weight24 months after enrollmentExpected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
ASPIRE-Phone Lifestyle Coaching
Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA) Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
162
ASPIRE-Group Lifestyle Coaching
On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA) Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle.
160
MOVE! Usual Care
Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
159
Total481

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath024
Overall StudyLost to Follow-up15916
Overall StudyLost to follow-up at 12-mo272926
Overall StudyPregnancy100
Overall StudyRefused 12-mo assessment319
Overall StudyRefused Year 21164
Overall StudyRemoved due to behavior112
Overall StudyWithdrawal by Subject1388

Baseline characteristics

CharacteristicASPIRE-Group Lifestyle CoachingMOVE! Usual CareASPIRE-Phone Lifestyle CoachingTotal
Age, Continuous54.9 years
STANDARD_DEVIATION 9.5
54.6 years
STANDARD_DEVIATION 10.5
55.4 years
STANDARD_DEVIATION 10
55.0 years
STANDARD_DEVIATION 10
Charlson Index1.2 units on a scale
STANDARD_DEVIATION 1.4
1.2 units on a scale
STANDARD_DEVIATION 1.6
1.0 units on a scale
STANDARD_DEVIATION 1.3
1.1 units on a scale
STANDARD_DEVIATION 1.5
Depression
No
98 participants100 participants127 participants325 participants
Depression
Yes
62 participants59 participants35 participants156 participants
Diabetes
No
96 participants99 participants109 participants304 participants
Diabetes
Yes
64 participants60 participants53 participants177 participants
Education, years
13-15
81 participants92 participants81 participants254 participants
Education, years
16 or more
42 participants26 participants40 participants108 participants
Education, years
Less than 13
34 participants36 participants38 participants108 participants
Education, years
Missing
3 participants5 participants3 participants11 participants
Health-related disability
No
73 participants71 participants88 participants232 participants
Health-related disability
Yes
87 participants88 participants74 participants249 participants
Income less than $20k
Income $20k or more
90 participants88 participants107 participants285 participants
Income less than $20k
Income less than $20k
70 participants71 participants55 participants196 participants
Race/Ethnicity, Customized
Black
65 participants64 participants67 participants196 participants
Race/Ethnicity, Customized
Other
1 participants4 participants4 participants9 participants
Race/Ethnicity, Customized
White
94 participants91 participants91 participants276 participants
Sex: Female, Male
Female
26 Participants20 Participants26 Participants72 Participants
Sex: Female, Male
Male
134 Participants139 Participants136 Participants409 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
45 / 16233 / 16015 / 159
serious
Total, serious adverse events
0 / 1620 / 1600 / 159

Outcome results

Primary

Change in Weight

Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data

Time frame: 12 months after enrollment

ArmMeasureValue (MEAN)
ASPIRE-Phone Lifestyle CoachingChange in Weight-1.4 Kilograms
ASPIRE-Group Lifestyle CoachingChange in Weight-2.8 Kilograms
MOVE! Usual CareChange in Weight-1.4 Kilograms
Comparison: All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.p-value: <0.05Regression, Linear
Secondary

Change in Weight

Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.

Time frame: 24 months after enrollment

Population: Includes only individuals who formally consented to participate in the second 12 months of the study.

ArmMeasureValue (MEAN)
ASPIRE-Phone Lifestyle CoachingChange in Weight-1.91 kilograms
ASPIRE-Group Lifestyle CoachingChange in Weight-1.3 kilograms
MOVE! Usual CareChange in Weight-1.8 kilograms

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026