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First-time Parents Physical Activity Intervention

2020년 12월 10일 업데이트: Ryan Rhodes, University of Victoria

This study will be investigating whether a theory-based physical activity intervention can maintain/improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over the eight months of having a child compared to a control group of new parents.

Hypothesis: The theory-based condition will change salient underlying motives (theory of planned behaviour constructs) for physical activity. Health-related fitness and quality of life will also be higher for this condition in comparison to the control condition. (Note: improvements in both groups of mothers may occur due to recovery from pregnancy, but our hypotheses will still hold). All outcomes will remain significantly higher at eight months in the theory-based condition compared to the standard condition

연구 개요

상태

완전한

정황

상세 설명

Clearly the prevention of chronic disease through physical activity promotion is an important research area. Identifying critical life transitions in people's physical activity behaviours may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. Our proposed study will examine whether a brief, theory-based, and cost-effective intervention can help maintain/improve the physical activity behaviours of new parents in their first eight months of the parenthood experience. The study represents the first couple-based physical activity initiative in the parenthood literature; prior research has only focused on mothers and has shown short-term changes in physical activity that return to baseline levels after approximately one month. In light of the potential for couples to provide important sources of social support for the other parent within the household, it would seem remiss not to consider parenting interventions that are directed and evaluated at the dyadic level. Furthermore, couple-based interventions in other populations and other health behaviour domains have been shown as more effective than individual-level intervention. The long-term impact of this study, if the results support our hypotheses, has utility to prevent or curb the decline of physical activity habits based on our findings. This research has the clear potential to be applied to population-level knowledge translation sources such as prenatal classes, physician offices, and other early parent learning/counselling avenues.

Parents will be measured at baseline (2 months post partum) with two assessment points at six weeks (3.5 months post partum) and three months (5 months post partum) and a final follow-up assessment six months later (8 months post partum). The content of the theory-based intervention was derived from the results of our prior CDA and SSHRC-funded longitudinal trial of new parents using the theory of planned behaviour to predict changes in physical activity, the content used in prior pilot-level studies that has already been successful in changing short-term physical activity in mothers 26-30, and the content of our current CIHR-funded study of physical activity goal planning.

Primary Research Question

1) Does the theory-based condition improve adherence to regular physical activity among new parents when compared to those in the control condition at eight months after the birth of their first child? Hypothesis: Adherence will be higher for parents in the theory-based condition in comparison to parents in the control condition after controlling for possible confounds. The adherence effect may wane over time from the initial measurement period of two months after the onset of parenthood but all outcomes will remain significantly higher at eight months.

Secondary Research Questions

  1. Does the theory-based condition improve motivational, health-related quality of life, and health-related fitness outcomes among new parents when compared to those in the control condition at eight months after the onset of parenthood? Hypothesis: The theory-based condition will change salient underlying motives (theory of planned behaviour constructs) for physical activity because its basis is from the key results of our prior longitudinal trial of new parents. Health-related fitness and quality of life, will also be higher for this condition in comparison to the control condition, (footnote: improvements in both groups of mothers may occur due to recovery from pregnancy, but our hypotheses will still hold). All outcomes will remain significantly higher at eight months in the theory-based condition compared to the standard physical activity education group.
  2. Can group differences among new parents with regard to these motivational, behavioural, and health-related fitness outcomes be explained through a mediation model?

    Hypothesis: The covariance of the assigned conditions (theory-based, standard) on adherence will be explained by changes in the salient underlying motives for physical activity (i.e., manipulation check). In turn, the covariance between these salient underlying motives and health-related outcomes will be explained by physical activity adherence among conditions.

  3. Can motivational variables predict adherence? Do these differ by condition?

    Hypothesis: The approach will test Ajzen's 39 theory of planned behavior. Affective attitude and perceived behavioural control will predict intention, intention will predict adherence across conditions similar to our prior study with this population 41.

  4. Is there a seasonal, initial physical activity status, mental health or gender difference across primary outcomes by assigned condition?

Hypothesis: No differences in gender or season are hypothesized based on our lack of evidence in the prior trial41, but these are exploratory research questions because there is limited research at present to make any definitive statement. The examination of whether the intervention affects maintenance or increases in baseline physical activity via stratification of baseline values will also be explored as will the assessment of baseline depression and anxiety.

Recruitment: We began feasibility recruitment and procedures last year in order to establish our protocol, and pilot our intervention material. Based on this feasibility study, participant recruitment is being achieved with both active (pregnancy class visits) and passive recruitment techniques (notice of research and poster). The active recruitment is being conducted through community organizations offering prenatal classes and programming for first-time parents. The project coordinator and research assistants associated with this project are the main point of contact for potential participants. Organizations are contacted by the research coordinator and asked if they are interested in giving 10 minutes of time (prenatal class, workshop).

연구 유형

중재적

등록 (실제)

132

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • British Columbia
      • Victoria, British Columbia, 캐나다, V8P-5C2
        • University of Victoria

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Married or common law couples
  • Living in Greater Victoria
  • Expecting first child
  • 18 years of age or older

Exclusion Criteria:

  • younger than 18
  • Expecting second or third child

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Theory-based group
The theory-based intervention group will receive strategies based on the Theory of Planned Behaviour to help increase physical activity among couples. Parents will receive materials on how to work together.
Workbooks and mini-counselling sessions will be provided to participants in this group.
간섭 없음: Information group
The information group will serve as the control group and will receive informational materials on the benefits of physical activity.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Objective and Self-report Physical activity
기간: Baseline, 6 weeks, 3.5 months, and 6 months
Physical activity will be measured objectively for 7 consecutive days using the wGT3X-BT Activity Monitor combined with self-report of PA using the Godin Leisure-Time Exercise Questionnaire (LSI) at each time period.
Baseline, 6 weeks, 3.5 months, and 6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Demographic information
기간: Baseline
Basic information on gender, age, ethnicity, income, education level will be gathered.
Baseline
Health measures
기간: Baseline and 6 months
Information on leave status, child care status, diet, sleep (Pittsburgh sleep quality index) and breastfeeding status, smoking, alcohol consumption will be included in this assessment.
Baseline and 6 months
Motivation for physical activity
기간: Baseline, 6 weeks, 3.5 months, 6 months
Motivation will be measured using the constructs of the theory of planned behaviour. Items will measure all components of the model (affective attitude, instrumental attitude, injunctive norm, descriptive norm, perceived control, planning) including behavioural, normative, and control beliefs.
Baseline, 6 weeks, 3.5 months, 6 months
Health related quality of life/psychosocial distress
기간: Baseline, 6 weeks, 3.5 months, 6 months
This will be assessed with parents using the Satisfaction with Life Scale. In addition, we will assess depressive and anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS), which also has sound reliability and validity compared to similar instruments.
Baseline, 6 weeks, 3.5 months, 6 months
Health related fitness
기간: Baseline and 6 months
We will assess the key components of health-related physical fitness including body composition, aerobic fitness and musculoskeletal fitness which are valid for males and females.
Baseline and 6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ryan Rhodes, PhD., University of Victoria
  • 연구 책임자: Mark Beauchamp, PhD, University of British Columbia
  • 연구 책임자: Chris Blanchard, PhD, Dalhousie
  • 연구 책임자: Darren Warburton, PhD, University of British Columbia
  • 연구 책임자: Danielle Downs, PhD, Penn State University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 11월 1일

기본 완료 (실제)

2018년 3월 1일

연구 완료 (실제)

2018년 7월 1일

연구 등록 날짜

최초 제출

2014년 4월 19일

QC 기준을 충족하는 최초 제출

2014년 11월 10일

처음 게시됨 (추정)

2014년 11월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 12월 10일

마지막으로 확인됨

2020년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 133614

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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