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A Pilot Factorial Trial of an Integrated Lifestyle Intervention

Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06116435
Enrollment
64
Registered
2023-11-03
Start date
2023-12-04
Completion date
2027-03-31
Last updated
2024-05-14

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

Conditions

Overweight and Obesity, Physical Inactivity

Keywords

physical activity, obesity, weight loss, nutrition, diet, lifestyle intervention

Brief summary

This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.

Interventions

BEHAVIORALPrevent T2

The PreventT2 curriculum is based on the original 2002 Diabetes Prevention Prevention (DPP) trial and follow-up studies. It promotes modest weight loss (5-7%) and increased physical activity through a lifestyle change program and also reflects new literature on self-efficacy, physical activity, and diet. There are 16 modules that will be delivered over 6 months. Participants will receive a calorie goal and be asked to count calories in order to reduce their caloric intake.

BEHAVIORALMove group-based classes

The Move physical activity support program group-based classes are based on Self-Determination Theory and encourage improvements in autonomous motivation for physical activity. These group-based classes are integrated within the Prevent T2 program curricula.

BEHAVIORALFitness Membership

Participants will receive 6 months of the Peloton fitness membership. This includes access to livestream and on-demand fitness classes including walking, strength training, yoga, meditation, stretching, etc.

BEHAVIORALMental Imagery

Participants will receive access to positive mental guided imagery recordings. Recordings describe a pleasant experience while walking and range from 2-8 minutes in duration.

BEHAVIORALMove 1:1 Support

Participants will meet individually with their class instructor to receive personalized recommendations on how to incorporate messages from the Move group-based classes into their daily lives. Sessions are based on Self-Determination Theory and will last approximately 45 minutes.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Trials participants will know their intervention condition as will the lay coach involved in delivering the intervention. Assessors measuring body composition (DXA), self-reported energy intake, and metabolic parameters will be blinded to participant condition.

Intervention model description

2x2x2 full factorial pilot randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* For all types of research participants: * Men and Women * Age 18-65 years * Have access to a computer and/or smart phone, and Wi-Fi * Speak English (since all study materials are in English and the intervention will be delivered in a group-class setting with a coach who speaks English, we are only able to accommodate English-speakers at this time) * For the patient participants only: * Body Mass Index 25-45 kg/m2 * Insufficiently active (defined as \<150 min/week of voluntary exercise at moderate intensity over the past 3 months) * Willing not to enroll in any other formal weight loss, or physical activity program over the next 5 months. * Have a primary care physician (or has access to a healthcare professional and/or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. * Capable and willing to give informed consent, understand

Exclusion criteria

, attend the Move program sessions, and complete outcome measures. * For the provider participants only: * \>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the Move physical activity support program - Qualitative6 monthsAcceptability of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
Feasibility of the Move physical activity support program - Qualitative6 monthsFeasibility of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.

Secondary

MeasureTime frameDescription
Acceptability of the Move physical activity support program components - Quantitative6 monthsAcceptability of the integrated Move physical activity support program components will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. Scores range from -100 to +100, with higher scores indicating a better outcome.
Feasibility of the Move physical activity support program - Quantitative6 monthsFeasibility of the Move physical activity support program will be assessed using the Perceived Characteristics of Intervention Scale (PCIS) collected only at the level of the provider. Scores range from 0 to 4, with higher scores indicating a better outcome.

Countries

United States

Contacts

Primary ContactDanielle M Ostendorf, PhD
danielle.ostendorf@cuanschutz.edu303-724-9203
Backup ContactDanielle M Ostendorf, PhD

Outcome results

None listed

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