An interventional study of Motivational interviewing telephone counseling in Physical Activity, PreDiabetes and Diabetes, sponsored by Kaiser Permanente. Completed. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Other
The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes. The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit. The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's enrollment of 67 is close to the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Compared within Prediabetic State, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.
Behavioral: Motivational interviewing telephone counseling
Participants in the usual care arm received a packet of places near their home in which they could engage in physical activity if they chose.
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.
Participants who met eligibility criteria and who were scheduled for an outpatient visit with their primary care provider were invited to participate in the study. Feasibility was assessed by the investigators' ability to recruit 60 participants into the pilot trial.
Time frame: The intervention lasted 24 weeks.
Moderate to Vigorous Physical Activity
Participants were mailed an Actigraph model 7185 accelerometer and asked to wear it over their right hip for 7 consecutive days and return the monitor through the mail. Data were analyzed to assess daily moderate to vigorous physical activity using the Freedson cutpoints.
Time frame: Assessments were made a baseline and approximately 24 weeks after baseline assessments.
Motivation for Physical Activity
The 30-item Motivation for Physical Activities Measure was used to measure motivation for physical activity. The scale has 5 factors: interest/enjoyment, competence, appearance, fitness, and social motivations. A mean score for each factor was determined for each participant.
Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
Physical Activity Self-Regulation
This is a 16-item scale with the following factors: external regulation, introjected regulation, identified regulation, and intrinsic regulation. A Relative Autonomy Index is formed from the factors, with the higher scores indicating greater autonomy toward physical activity.
Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline.
No study locations are listed for this record.
Plan to share: No
Ran from Jun 2015 to primary completion in Jul 2017, 25 months.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 25 months is close to that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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